NDC 0135-0637 Parodontax Active Gum Repair

NDC Product Code 0135-0637

NDC 0135-0637-01

Package Description: 1 TUBE in 1 CARTON > 96.4 g in 1 TUBE

NDC 0135-0637-02

Package Description: 1 TUBE in 1 CARTON > 22.7 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Parodontax Active Gum Repair with NDC 0135-0637 is product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The product's dosage form is and is administered via form.

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:

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.


Product Labeler Information

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

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
Start Marketing Date: 01-04-2021 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Parodontax Active Gum Repair Product Label Images

Parodontax Active Gum Repair Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)




  • •aids in the prevention of dental cavities. •helps control bleeding gums. •helps interfere with harmful effects of plaque associated with gingivitis.

Stop Use And Ask A Dentist If

  • •gingivitis, bleeding, or redness persists for more than 2 weeks. •you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease

Keep Out Of Reach Of Children Under 6 Years Of Age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


  • •adults and children 2 years of age and older: •brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. •to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established. •children under 2 years of age: Consult a dentist or doctor.

Other Information

  • •products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. •this product is specially formulated to help prevent staining. •do not store above 25ºC (77ºF)

Inactive Ingredients

Glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Additional Information

ALWAYS FOLLOW THE LABELParodontax ACTIVE GUM REPAIRTo keep your gums healthy, It’s important for the seal between the gum and the teeth to be tight. When plaque bacteria builds up along the gum line, this may loosen the gum seal which leads to gum problems.New parodontax Active Gum Repair is a daily toothpaste formulated to help reverse early signs of early gum damage by targeting plaque, the main cause of gum problems. The active ingredient kills plaque bacteria at the gum line to help keep the seal tight between gums and teeth and prevent early gum problems.Kills plaque bacteria at the gum lineFor tight gum sealHealthy gums and teethTrademarks are owned by or licensed to the GSK group of companies.©2020 GSK group of companies or its licensor.Distributed by:GSK Consumer HealthcareWarren, NJ 07059

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