NDC 69968-0540 Aveeno Baby Eczema Therapy Nighttime Balm

Aveeno Baby Eczema Therapy Nighttime Balm with NDC 69968-0540 is a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Aveeno Baby Eczema Therapy Nighttime Balm is oatmeal. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Aveeno Baby Eczema Therapy Nighttime Balm Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

• OATMEAL 10 mg/g

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:

• RxCUI: 240651

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

• GLYCERIN (UNII: PDC6A3C0OX)
• WATER (UNII: 059QF0KO0R)
• CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
• ISOCETYL ALCOHOL (UNII: 1800H64066)
• DIMETHICONE (UNII: 92RU3N3Y1O)
• CETYL ALCOHOL (UNII: 936JST6JCN)
• BENZYL ALCOHOL (UNII: LKG8494WBH)
• ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
• SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
• BENZOIC ACID (UNII: 8SKN0B0MIM)
• STEARIC ACID (UNII: 4ELV7Z65AP)
• DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
• POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
• P-ANISIC ACID (UNII: 4SB6Y7DMM3)
• MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
• SODIUM HYDROXIDE (UNII: 55X04QC32I)
• OAT KERNEL OIL (UNII: 3UVP41R77R)
• CERAMIDE NP (UNII: 4370DF050B)
• CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
• OAT (UNII: Z6J799EAJK)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

• Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacologic Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

• Allergens - [CS]
• Cell-mediated Immunity - [PE] (Physiologic Effect)
• Dietary Proteins - [CS]
• Grain Proteins - [EXT]
• Increased Histamine Release - [PE] (Physiologic Effect)
• Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
• Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
• Plant Proteins - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Johnson & Johnson Consumer Inc.
Labeler Code: 69968
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Start Marketing Date: 03-25-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.