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 122 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sanar Naturals Arnica Reforzada CAMPHOR Sanvall Enterprises, Inc 1921a4b1-cd36-195e-e063-6294a90a8793 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Arnica Pain Releiving Roll On with Camphor CAMPHOR Sanvall Enterprises, Inc 173db0e2-611f-55b9-e063-6394a90ac987 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Camphor CAMPHOR Sanvall Enterprises, Inc 1921e851-cf83-0bdb-e063-6294a90a357f 2024-10-31 Warnings Exact identifier application number: M017 cortisone HYDROCORTISONE CVS Pharmacy c766deac-d993-4e48-a5c3-4cfde7338dff 2024-10-31 Warnings Exact identifier application number: M017 Walgreens Pain Relieving with Lavender Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 6c7b39c8-5b65-430a-a529-5b6b14adce18 2024-10-31 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Plus Turmeric Analgesic TROLAMINE SALICYLATE Walgreen Company f3a121bc-7572-49a4-9822-2b6d858c19d2 2024-10-31 Warnings Exact identifier application number: M017 dg health hydrocortisone HYDROCORTISONE Dolgencorp, LLC 27dc9e09-fc4f-4b66-a303-177725f3a513 2024-10-31 Warnings Exact identifier application number: M017 basic care hydrocortisone HYDROCORTISONE Amazon.com Services LLC f5419859-3f9f-43ff-9a3f-6aa81af044f0 2024-10-31 Warnings Exact identifier application number: M017 ARCTIC RELIEF MENTHOL, UNSPECIFIED FORM STRATUS PHARMACEUTICALS INC d27fbc17-46b7-4d52-ba29-c99b6c63144a 2024-10-31 Warnings Exact identifier application number: M017 Pain Relief Gel-Patch LIDOCAINE, MENTHOL R & Y Group, LLC fe0478d8-2f06-cd56-e053-6294a90a58e5 2024-10-30 Warnings Exact identifier application number: M017 JOINT-RITIS PAIN RELIEVING ROLL-ON MENTHOL Lifeline Naturals of America, Inc. ec5d99c4-6bba-45d1-84e0-12fb7cb31495 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving with Turmeric Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 317ec4fb-cff0-461d-9ca0-299527a3686d 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Analgesic CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Walgreen Company 3215a676-104c-43c3-aa36-b30d5b67799a 2024-10-30 Warnings Exact identifier application number: M017 Ultra-Strength Pain Relief Analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM TARGET CORPORATION 159c5a84-bf68-41dd-a2d3-bc2402037244 2024-10-30 Warnings Exact identifier application number: M017 DG Health Cold n Hot Pain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM Dolgencorp Inc 8fe13b85-ab74-42f8-a664-d3d2959921ac 2024-10-30 Warnings Exact identifier application number: M017 DEBACHERE Butt Balm After Care Antiseptic Pain Relief BENZOCAINE, BENZALKONIUM CHLORIDE DE.BACHERE USA LLC 8ba42864-69bf-455c-98d4-7f4ff94edceb 2024-10-29 Warnings Exact identifier application number: M017 Signature Care Hydrocortisone HYDROCORTISONE Safeway beefab66-b056-4bf1-b047-0780704ab87e 2024-10-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE H E B 15eb4676-5f6e-4c28-b5b9-4e45412dc37a 2024-10-29 Warnings Exact identifier application number: M017 Rael PAIN RELIEF ROLL-ON Analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM Rael, Inc. e6c49606-7c13-4dc6-a22d-ba54173ba788 2024-10-28 Warnings Exact identifier application number: M017 Monistat Care Instant Itch Relief BENZOCAINE Insight Pharmaceuticals LLC 4e9dc791-419f-4c79-aed4-760f8c17a5dd 2024-10-25 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