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 130 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SANTO REMEDIO Alivio Pain Relieving Lavender Scent LIDOCAINE HYDROCHLORIDE, MENTHOL SANTO REMEDIO LLC ab53c7f2-a768-4f36-89d6-e128a1a940c2 2024-08-05 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT CVS Health ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3 2024-08-02 Warnings Exact identifier application number: M017 Anti-Itch Vulva Cream 1 Hydrocortisone Acetate HYDROCORTISONE ACETATE The Honey Pot Company LLC 6f32b536-6ebf-49a8-abb6-2a1daae2f6d7 2024-08-01 Warnings Exact identifier application number: M017 Anti Itch Soothing 1 Pramoxine Hydrochloride PRAMOXINE HYDROCHLORIDE The Honey Pot Company LLC 8bfeea34-25d5-4721-a17f-d9f1d0084cc3 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Arthritis Achy Foot and Muscle METHYL SALICYLATE The Avon Company 1f440f60-cfc4-511e-e063-6294a90a87db 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Maximum Strength Cracked Heel BENZALKONIUM CHLORIDE, LIDOCAINE The Avon Company 1f45752e-4a55-431e-e063-6294a90aa57a 2024-08-01 Warnings Exact identifier application number: M017 Relief MENTHOL La Mend, Inc. 1f92de3a-7180-5884-e063-6294a90aebf5 2024-08-01 Warnings Exact identifier application number: M017 Meijer Medicated Foot Powder MENTHOL Meijer Distribution 07ec6c20-73c4-e5e4-e063-6294a90a7e55 2024-07-29 Warnings Exact identifier application number: M017 Ralli Rapid Pain Relief MENTHOL Troy Manufacturing, Inc. e05ec3b7-e9ab-4eaa-8518-86304336697c 2024-07-29 Warnings Exact identifier application number: M017 Walgreens Roll-On CAPSAISIN 0.1% Walgreens Co 1e65bf31-15c7-5e6a-e063-6394a90ac956 2024-07-29 Warnings Exact identifier application number: M017 Camphotrex CAMPHOR, MENTHOL PureTek Corporation 3b6c6eef-e92d-497d-afe8-82356637c2b8 2024-07-26 Warnings Exact identifier application number: M017 Camphotrol CAMPHOR, MENTHOL PureTek Corporation ccac9f37-a374-4765-e053-2a95a90ad2f7 2024-07-26 Warnings Exact identifier application number: M017 Real Time Pain Relief Foot MENTHOL Real Time Products Inc. 29c8e06d-9b29-44f9-ac21-9160d06475cb 2024-07-24 Warnings Exact identifier application number: M017 Capsaicin 0.075 Percent CAPSAICIN Alexso, Inc 33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd 2024-07-22 Warnings Exact identifier application number: M017 TIDL Pain Relief CRYO Therapy Limited Edition PAIN RELIEF CRYO THERAPY LIMITED EDITION Shenzhen Sam Technology Co., Ltd. 1d966b67-fd9c-eab6-e063-6294a90aa75e 2024-07-19 Warnings Exact identifier application number: M017 Fruit of the Earth Aloe Vera Cool Blue LIDOCAINE HYDROCHLORIDE Fruit of the Earth, Inc. 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79 2024-07-19 Warnings Exact identifier application number: M017 Ultra Balm MENTHOL AND METHYL SALICYLATE Ling Nam Medicine Factory (H.K.) Ltd. de997baf-aa04-474e-b912-3fc67e720d0b 2024-07-19 Warnings Exact identifier application number: M017 Ling Nam Hak Kwai Oil TURPENTINE OIL Ling Nam Medicine Factory (H.K.) Ltd. 3f16cce3-366f-41f3-8829-6de4082a8c19 2024-07-19 Warnings Exact identifier application number: M017 Koong Yick Hak Kwai Oil TURPENTINE OIL Ling Nam Medicine Factory (H.K.) Ltd. bc33e185-3b42-98b5-e053-2995a90a6308 2024-07-18 Warnings Exact identifier application number: M017 Koong Yick Hung Fa METHYL SALICYLATE Ling Nam Medicine Factory (H.K.) Ltd. 9c8a121d-6da2-4435-a2d7-a0b71d10740d 2024-07-18 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