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 2026-12-31
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 27 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SPARTAN LIDOCAINE TIV PRIME SRL 4e04146a-ed19-2271-e063-6394a90a50f0 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Lidocaine LIDOCAINE Walgreen Co. 41d5bdc4-66c8-31ab-e063-6394a90a1195 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Patch LIDOCAINE, MENTHOL Walgreen Co. 41d64a88-90fc-27ca-e063-6294a90a602b 2026-03-27 Warnings Exact identifier application number: M017 Softlips Naturals Medicated CAMPHOR, MENTHOL The Mentholatum Company 4e05d134-6c7f-1501-e063-6294a90ad27d 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Patch XL MENTHOL Walgreen Co. 41e92435-7f77-a593-e063-6394a90a4b38 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Back Patch MENTHOL Walgreen Co. 41e81110-4b79-1fa6-e063-6394a90ae90c 2026-03-27 Warnings Exact identifier application number: M017 Softlips Naturals Medicated Elderberry Acai CAMPHOR, MENTHOL The Mentholatum Company 4e0743a6-d450-043b-e063-6394a90ad1c2 2026-03-27 Warnings Exact identifier application number: M017 QFSN Pain Relief Cream PAIN RELIEF CREAM Qiaofusheng Pharmaceuticals Co., Ltd. 4d215da1-87f5-d35d-e063-6394a90ac348 2026-03-27 Warnings Exact identifier application number: M017 FlexSport Roll On METHYL SALICYLATE Pharmadel LLC bf8de3da-7628-6112-e053-2995a90a8e16 2026-03-26 Warnings Exact identifier application number: M017 Kofal Original METHYL SALICYLATE Pharmadel LLC 984780fd-496b-150b-e053-2995a90aed77 2026-03-26 Warnings Exact identifier application number: M017 Kofal Fuerte METHYL SALICYLATE Pharmadel LLC 98488a07-eba0-2b4e-e053-2995a90ad6ab 2026-03-26 Warnings Exact identifier application number: M017 Kofal Max Power MENTHOL Pharmadel LLC fe1f1408-b0cb-67a4-e053-6394a90ad609 2026-03-26 Warnings Exact identifier application number: M017 Kofal METHYL SALICYLATE Pharmadel LLC 9cac377d-97bc-f0b7-e053-2a95a90a2e12 2026-03-26 Warnings Exact identifier application number: M017 Milagroso CAMPHOR Pharmadel LLC 12b0401c-84d5-07cd-e063-6394a90a052c 2026-03-26 Warnings Exact identifier application number: M017 Ubredol METHYL SALICYLATE Pharmadel LLC fe96eead-1722-c05d-e053-6394a90a850f 2026-03-26 Warnings Exact identifier application number: M017 DZUL PAIN FREEZE INSTANT PAIN RELIEF MENTHOL Caball Sales, Inc. 4df3abcc-17f3-17f2-e063-6294a90afcca 2026-03-26 Warnings Exact identifier application number: M017 Equate Cool and Heat Extra Strength MENTHOL Wal-Mart Stores Inc ca3088a7-e1ec-4e69-80d9-fd0051bde938 2026-03-25 Warnings Exact identifier application number: M017 Ultra Strength Muscle Rub - CVS Health Ultra Strength Muscle Rub CAMPHOR, MENTHOL, METHYL SALICYLATE CVS Pharmacy 2ea95529-ec4b-c2ce-e063-6394a90a0739 2026-03-25 Warnings Exact identifier application number: M017 NUMBING CREAMS MENTHOL LIDOCAINE Yongchun Lihui Trading Co., Ltd. 4dd38cdf-d644-6da0-e063-6294a90afb3d 2026-03-25 Warnings Exact identifier application number: M017 ANTIPHLAMINE L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE Masaem Company 4dd3ab12-6cd3-1060-e063-6394a90a2dec 2026-03-25 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