Home NDC 76281-522 Nighttime Sleep-Aid
Product NDC 76281-522
11-digit product format 762810522
Labeler code 76281
Product ID 76281-522_f1654da1-64f7-4c2b-9201-3a7af430ba37
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCI
Dosage form LIQUID
Route ORAL
Labeler AptaPharma Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-01
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 50 mg/30mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nighttime Sleep-Aid
Brand name suffix Non-Habit Forming
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1248354 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76281-522-24 Nighttime Sleep-AidNon-Habit Forming 118 mL in 1 BOTTLE LIQUID 118 3 76281-522-25 Nighttime Sleep-AidNon-Habit Forming 177 mL in 1 BOTTLE LIQUID 177 3 76281-522-28 Nighttime Sleep-AidNon-Habit Forming 354 mL in 1 BOTTLE LIQUID 354 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76281-522 NIGHTTIME SLEEP-AID NON-HABIT FORMING (DIPHENHYDRAMINE HCI) LIQUID [APTAPHARMA INC.] 3 Current NDC, Legacy NDC, 3 package rows 20231231_ed0ba7aa-e794-43da-b576-6b9945bf7477.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 86 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freds Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE FRED'S, INC. 7502eebe-11c5-4e9e-b427-b87180a84349 2025-07-16 Warnings Exact identifier application number: M017 PROINNATE Numbing Cream MENTHOL Guangzhou Haishi Biological Technology Co., Ltd. 39688b2b-c1fe-cd86-e063-6394a90a5345 2025-07-16 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE ViolaCare, Inc. 8f0ba6e7-8aa4-443e-99ae-a255085ddfec 2025-07-15 Warnings Exact identifier application number: M017 TopCare Hydrocortisone Intensive Healing Formula HYDROCORTISONE Topco Associates LLC 7daafc44-e2a4-4f1b-bfca-3309a8e9a920 2025-07-15 Warnings Exact identifier application number: M017 Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE TARGET Corporation 72c3889c-b743-4728-a315-6e4063e00200 2025-07-15 Warnings Exact identifier application number: M017 Shopko Hydrocortisone Maximum Strength HYDROCORTISONE Shopko Stores Operating Co., LLC 0431a6af-4c9a-4bbd-a535-cba31a5e53cc 2025-07-15 Warnings Exact identifier application number: M017 Freds Hydrocortisone with Aloe HYDROCORTISONE FRED'S, INC. 076503bf-8238-4739-bb1c-c385e72f8a96 2025-07-15 Warnings Exact identifier application number: M017 Shopko Hydrocortisone HYDROCORTISONE Shopko Stores Operating Co., LLC 92bcbde3-401a-4301-854e-c352852317d6 2025-07-15 Warnings Exact identifier application number: M017 TopCare Hydrocortisone HYDROCORTISONE Topco Associates LLC bd3585fa-3b48-49b7-8ad1-749bf1e31ed5 2025-07-15 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Pain Relieving METHYL SALICYLATE Puretek Corporation 376797ff-cf13-a3c6-e063-6394a90a9de1 2025-07-15 Warnings Exact identifier application number: M017 TIGER BALM PAIN RELIEVING CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM Haw Par Healthcare Ltd. 440e97bc-bd97-4733-9955-643b18e7fb18 2025-07-15 Warnings Exact identifier application number: M017 Tiger Balm Pain Relieving Hydrogel Large CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM Haw Par Healthcare Ltd. 064d04ca-184d-492b-867c-beaa165ab3e0 2025-07-14 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Cream METHYL SALICYLATE Medcore LLC 143f76bf-2de4-466a-8a6b-d6ab6314a2c3 2025-07-14 Warnings Exact identifier application number: M017 BLUESPRING Doctors Pain Formula Pain Relief MENTHOL ACA MANAGEMENT LLC 98f3f719-792f-4a93-95b1-90072e0f8bf4 2025-07-14 Warnings Exact identifier application number: M017 Shopko Anti-Itch DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Shopko Stores Operating Co., LLC 130119eb-b87e-4a07-8d2a-317369bfa541 2025-07-14 Warnings Exact identifier application number: M017 Equate Hydrocortisone Intensive Healing Formula HYDROCORTISONE Wal-Mart Stores Inc. 635b49c4-54d2-4b6d-bee8-851fc2c7ca9c 2025-07-14 Warnings Exact identifier application number: M017 ULTRA STRENGTH ZHENG GU SHUI MENTHOL AND CAMPHOR GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD 53397663-044d-4e48-989b-2c6257af5f84 2025-07-14 Warnings, Adverse reactions Exact identifier application number: M017 TIGER BALM PAIN RELIEVING HYDROGEL CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM Haw Par Healthcare Ltd. cb60037f-bceb-4090-a5e4-bdda0cbf9f5c 2025-07-14 Warnings Exact identifier application number: M017 Avedana Hydrocortisone Cream with Aloe HYDROCORTISONE Unipack LLC 2a55c426-39b4-4d94-b6b4-6c548c9685e9 2025-07-13 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE ACETATE Rite Aid Corporation cb6e0bed-2ea1-49d2-89e7-2554e7565b74 2025-07-11 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76281-522-24 76281052224 118 mL in 1 BOTTLE (76281-522-24) 118 ml 2018-01-01 0000-00-00 No No Current 76281-522-25 76281052225 177 mL in 1 BOTTLE (76281-522-25) 177 ml 2018-01-01 0000-00-00 No No Current 76281-522-28 76281052228 354 mL in 1 BOTTLE (76281-522-28) 354 ml 2018-01-01 0000-00-00 No No Current