Nighttime Sleep Aid Capsule, Liquid Filled
NDC Package 68391-613-92
Package Information
Nighttime Sleep Aid (diphenhydramine hydrochloride) capsules is usesfor the relief of occasional sleeplessnessreduces time to fall asleep if you have difficulty falling asleep. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Bjwc (berkley & Jensen / Bj's), this product is identified by NDC 68391-613 and is authorized under FDA application M010.
Identification & Billing
- RxCUI: 1049909 - diphenhydrAMINE HCl 25 MG Oral Capsule
- RxCUI: 1049909 - diphenhydramine hydrochloride 25 MG Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 68391 - Bjwc (berkley & Jensen / Bj's)
- 68391-613 - Nighttime Sleep Aid
- 68391-613-92 - 16 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- 68391-613 - Nighttime Sleep Aid
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 68391-613-92 identifies a specific commercial package of 16 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack of Nighttime Sleep Aid, a human over the counter drug labeled by Bjwc (berkley & Jensen / Bj's). This capsule, liquid filled is formulated for oral use and contains diphenhydramine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bjwc (berkley & Jensen / Bj's) on August 20, 2025. The current certification is valid through December 31, 2026.
How is this Bjwc (berkley & Jensen / Bj's) product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 68391061392. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.