Home NDC 76281-522-28 Nighttime Sleep-Aid
Product NDC 76281-522
Requested package NDC 76281-522-28
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 98 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Thera Plus Hydrocortisone Maximum Strength HYDROCORTISONE FOURSTAR GROUP USA, INC. c2bc8f0c-38ea-4124-bc51-bf22e6751a92 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Eczema Hydrocortisone Anti Itch HYDROCORTISONE Fourstar Group USA, Inc. 7c72217b-db9a-4573-9f14-4c11528fa452 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. fb89dca6-c0c0-4092-b3f5-e59c956c3d6c 2025-03-04 Warnings Exact identifier application number: M017 Peppermint soothing cream CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOL Henan Lijitang Medical Technology Co., Ltd. 2f6bc332-3006-710d-e063-6394a90acea5 2025-03-03 Warnings Exact identifier application number: M017 Thera Plus Pain Relief Arthritis and Muscle CAPSAICIN FOURSTAR GROUP USA, INC. dcff0a2d-7190-4b0c-abde-ba009b8ef005 2025-02-28 Warnings Exact identifier application number: M017 GoodSense Anti-Itch DIPHENHYDRAMINE HCL, ZINC ACETATE Geiss, Destin & Dunn, Inc 2f38bdfc-6135-1b8a-e063-6294a90a6703 2025-02-28 Warnings Exact identifier application number: M017 Capsaicin 0.05% Cream CAPSAICIN 0.05% Puretek Corporation 2cf17a28-711f-77bd-e063-6394a90a7061 2025-02-28 Warnings Exact identifier application number: M017 Lidocaine Pain-Relief Patches LIDOCAINE PATCH Meijer, Inc 2f247929-6bff-1e59-e063-6394a90acdba 2025-02-27 Warnings Exact identifier application number: M017 Lightning Products BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 555ac696-e761-4a5a-bed8-945dc64d5be5 2025-02-27 Warnings Exact identifier application number: M017 Hydrocortisone with aloe HYDROCORTISONE Encube Ethicals, Inc. 12a1774d-a97e-4787-b6b1-8e8cd40b7b70 2025-02-26 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Feminine Anti-Itch BENZOCAINE, RESORCINOL FOURSTAR GROUP USA, INC. 0007e3ea-882b-4000-8e70-2bcec2c08613 2025-02-26 Warnings Exact identifier application number: M017 Tattoo numbing cream LIDOCAINE BLOOMWELL GARDENS LLC 2ea9d34e-408d-f8d6-e063-6394a90a72a4 2025-02-26 Warnings Exact identifier application number: M017 Icy Hot Pro No-Mess CAMPHOR, MENTHOL Chattem, Inc. 9e8fedf5-fb59-4531-b288-715f851ee05b 2025-02-26 Warnings Exact identifier application number: M017 Family Wellness Max Strength 1 Hydrocortisone Cream HYDROCORTISONE Family Dollar Stores, Inc bca5ac2c-45cd-44e3-98f1-317a04e44d7d 2025-02-25 Warnings Exact identifier application number: M017 Tylenol Precise Nighttime Pain Relieving CAMPHOR, MENTHOL Kenvue Brands LLC 2ef4fe16-0820-6aad-e063-6294a90a8449 2025-02-25 Warnings Exact identifier application number: M017 LidoPro Pain Relief CAPSAICIN AND LIDOCAINE Preferred Pharmaceuticals Inc. c259ef92-5d07-4590-adf1-3a106333eee0 2025-02-21 Warnings Exact identifier application number: M017 Cortizone 10 Ultra Soothing Itch Relief HYDROCORTISONE Chattem, Inc. 8a9e2d32-a65f-4253-8041-4146f4e3b738 2025-02-21 Warnings Exact identifier application number: M017 AVCOO Pain Relief Roll On MENTHOL ADP Health Limited 420d8cdc-f47f-4d33-bf25-9033ff266c49 2025-02-19 Warnings Exact identifier application number: M017 AVCOO Pain Relief MENTHOL ADP Health Limited 700ce2cf-749e-40be-91c3-850d9b2168ca 2025-02-19 Warnings Exact identifier application number: M017 Sunburn Relief Gel LIDOCAINE HCL Jell Pharmaceuticals Pvt. Ltd 2e7c49de-5438-4858-e063-6294a90ad98c 2025-02-19 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 76281-522-28 76281052228 354 mL in 1 BOTTLE (76281-522-28) 354 ml 2018-01-01 0000-00-00 No No Current