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 118 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Strength Pain Relief Gel MENTHOL TELEBRANDS CORP d91b2e09-550e-4968-e053-2995a90ae323 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Cream LIDOCAINE 4% Telebrands Corp c3162ba8-ac2d-5a65-e053-2995a90af246 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief LIDOCAINE TELEBRANDS CORP d91ba9b1-083f-32e9-e053-2a95a90a9bd1 2024-11-20 Warnings Exact identifier application number: M017 DynaRub PAIN RELIEVING CREAM Dynarex Corporation 7f853941-a2d7-ed26-e053-2991aa0aa9ee 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions bcdc0322-bc75-4662-9c5a-d1be1d055252 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 604a30c9-2306-47a1-bd31-94b63639dd90 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 0b489420-3b5c-43c5-aab4-0e3720acf9ce 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions dd906129-a787-4352-856d-d7a915031a6e 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Arthritis Pain Relief Cream HISTAMINE DIHYDROCHLORIDE Walgreens Company 80d3031a-7fa9-4f5b-b85e-c7c6ef314801 2024-11-20 Warnings Exact identifier application number: M017 Anti-Itch Medicated Maximum Strength BENZOCAINE AND RESORCINOL Walgreens Company 7fd86dcb-edef-4d0d-b389-7ecea595fe67 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Pain Relief BENZOCAINE Walgreens Company 7cee7234-32cd-4bf3-8a6c-0882585eec7f 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Advanced Scar Gel ADVANCED SCAR GEL Walgreens Company 2c040475-a124-485c-933e-66b452f5ab46 2024-11-20 Warnings Exact identifier application number: M017 LidoPro Pain Relief CAPSAICIN AND LIDOCAINE Clinic Pharma 274611ea-7fc2-ba3f-e063-6294a90aa50f 2024-11-19 Warnings Exact identifier application number: M017 First Aid Only Sting Relief Pad BENZOCAINE Acme United Corporation 5087cbbd-1bbe-62ed-e054-00144ff8d46c 2024-11-19 Warnings Exact identifier application number: M017 Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL Acme United Corporation 6bb9a782-2394-4c8c-e053-2991aa0a08d4 2024-11-19 Warnings Exact identifier application number: M017 First Aid Only Sting Relief BENZOCAINE Acme United Corporation 697127d1-c02e-16d2-e053-2a91aa0a39fd 2024-11-19 Warnings Exact identifier application number: M017 First Aid Only Hydrocortisone 1% Anti-Itch HYDROCORTISONE Acme United Corporation e5597b11-b08e-99e1-e053-2a95a90a15a5 2024-11-19 Warnings Exact identifier application number: M017 Equate Cold Therapy Pain Relieving Roll-on Analgesic MENTHOL, UNSPECIFIED FORM Wal-Mart Stores, Inc. 4115f0ac-e12a-4e59-94f5-a47dcc7f8766 2024-11-18 Warnings Exact identifier application number: M017 Equate Cold Therapy Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM Wal-Mart Stores, Inc. ac6c2112-8692-4628-97d8-3a5a9f509766 2024-11-18 Warnings Exact identifier application number: M017 Equate Odor-Free Therapy Arthritis Analgesic TROLAMINE SALICYLATE Wal-Mart Stores, Inc. 1d73e7b6-c7f9-4680-b3e3-a954b91e1863 2024-11-18 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