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 2027-12-31 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 134 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Burn LIDOCAINE HYDROCHLORIDE JHK Inc 5a4ac4cc-015a-48e7-81f8-93a895049afd 2024-04-25 Warnings Exact identifier application number: M017 Cold Therapy Pain Relief MENTHOL, UNSPECIFIED FORM Walgreen Co. ede15818-5d17-477d-a8be-7b36bb0770a6 2024-04-22 Warnings Exact identifier application number: M017 Anti Itch HYDROCORTISONE Neilmed Pharmaceuticals Inc. 14b4f066-fde4-ac97-e063-6394a90ae64c 2024-04-20 Warnings Exact identifier application number: M017 Walgreens Cold Therapy Pain Relief Patch MENTHOL 5% Walgreens Company e33c90d1-2729-970f-e053-2995a90ad97a 2024-04-18 Warnings Exact identifier application number: M017 HealthWise Cold Therapy Pain Relief Patch MENTHOL Veridian Healthcare 0ce356e0-90a3-ad52-e063-6294a90a404a 2024-04-18 Warnings Exact identifier application number: M017 Walgreens Scalp Relief External analgesic HYDROCORTISONE Walgreen Company da0a24c7-9295-4f22-b2c7-40000dad4b81 2024-04-18 Warnings Exact identifier application number: M017 HealthWise 3x Medicated Pain Relief Patch CAMPHOR,MENTHOL, METHYL SALICYLATE Veridian Healthcare 164d4d62-00c0-e06d-e063-6294a90abd73 2024-04-17 Warnings Exact identifier application number: M017 TIGER Balm PAIN RELIEVING HYDROGEL CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM Haw Par Healthcare Ltd. ca601b02-e9be-4d8d-a384-c62553302ceb 2024-04-16 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 1592a40a-a647-34bd-e063-6394a90a0a10 2024-04-08 Warnings Exact identifier application number: M017 Menticam CAMPHOR, MENTHOL, METHYL SALICYLATE PureTek Corporation 081837a8-9669-be1f-e063-6394a90a9d20 2024-04-05 Warnings Exact identifier application number: M017 Pain Relieving Liniment CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM J.R. Watkins, LLC. 97a0c839-0927-4e54-aee2-ded2016ac4a0 2024-04-02 Warnings Exact identifier application number: M017 HealthWise Capsaicin Heat Patch CAPSAICIN Veridian Healthcare 150c1f09-8aa7-67ea-e063-6294a90a950a 2024-04-01 Warnings Exact identifier application number: M017 HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent LIDOCAINE HCI Veridian Healthcare 150d3e54-5c8d-19ef-e063-6394a90a70c2 2024-04-01 Warnings Exact identifier application number: M017 Meijer Pain Relief Cream LIDOCAINE Meijer Distribution 07ecee44-387a-cdce-e063-6294a90ab9c9 2024-03-27 Warnings Exact identifier application number: M017 Hydrocortisone Cream HYDROCORTISONE Trifecta Pharmaceuticals USA 141aa2a7-8789-1127-e063-6294a90a2d23 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. 1dc21c95-b419-4175-85f8-040b73060d37 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Roll-On Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. d94ae654-ce25-4bff-b9bd-24a0e0e8568a 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. f8bff018-fb4f-47b4-b8f8-4a496aede346 2024-03-20 Warnings Exact identifier application number: M017 Rugby Arthritis Pain Relieving Topical Analgesic CAPSAICIN Rugby Laboratories 8f1bc075-97ac-4154-8768-0d878104c3ba 2024-03-14 Warnings Exact identifier application number: M017 Rugby Ice Blue External Analgesic MENTHOL, UNSPECIFIED FORM Rugby Laboratories 2b65cb6a-4364-4770-b7b9-5c4637edd01a 2024-03-14 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