Home NDC 57896-224 Extra Strength Night Time Pain Medicine
Product NDC 57896-224
11-digit product format 578960224
Labeler code 57896
Product ID 57896-224_18fc1ad1-3502-bb79-e063-6394a90abac9
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET
Route ORAL
Labeler Geri-Care Pharmaceutical Corp
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-01
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57896-224-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57896-224-05 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 57896-224-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 57896-224-05 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 57896-224-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 57896-224-05 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57896-224-01 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57896-224-05 I Inactivated by FDA bd6a592717d7…303034d00443…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 57896-224-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 57896-224-05 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 57896-224-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 57896-224-05 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 Extra Strength Night Time Pain Medicine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 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 1092189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57896-224-01 Extra Strength Night Time Pain Medicine 100 in 1 BOTTLE TABLET 100 5 57896-224-05 Extra Strength Night Time Pain Medicine 50 in 1 BOTTLE TABLET 50 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-224 EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP] 5 Current NDC, Legacy NDC, 2 package rows 20240716_2b8f83ed-1ca9-49ac-9b2a-2609b68200f9.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 47 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GOOD REMEDIES Extra Strength Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d642d8e-c154-a970-e063-6294a90a03bf 2025-03-14 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4 2025-03-07 Warnings Exact identifier application number: M013 Redicare Non-Aspirin 500mg REDICARE NON-ASPIRIN, ACETAMINOPHEN 500MG Redicare LLC 2f229898-1777-732c-e063-6394a90a76bc 2025-03-04 Warnings, Adverse reactions Exact identifier application number: M013 Major Extra Strength Acetaminophen Liquid ACETAMINOPHEN Major Pharmaceuticals 2f3af4dd-45d5-87b4-e063-6294a90ab3cc 2025-02-28 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs ed9a71d6-a56e-416a-bb89-6d41307efc5a 2025-02-27 Warnings Exact identifier application number: M013 Aspirin ASPIRIN PD-Rx Pharmaceuticals, Inc. 77429b7f-78e4-42c0-8679-ae8da1748848 2025-02-26 Warnings Exact identifier application number: M013 AeroTab Non-Aspirin ACETAMINOPHEN 500MG ES Aero Healthcare faa3a4ef-3c70-06ca-e053-6394a90a512d 2025-02-26 Warnings Exact identifier application number: M013 Bufferin Regular Strength Pain Relief ASPIRIN Genomma Lab USA 3543b2bf-1062-468a-a5dc-eabb2408af8c 2025-02-25 Warnings Exact identifier application number: M013 Calmour Childrens Acetaminophen Strips Chewable ACETAMINOPHEN ORAL CHEWABLE 80 MG Calmour ae47b027-4f29-45bb-a8bd-812978932835 2025-02-22 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC f9de7c2f-016b-4f40-8b5e-141ad194be97 2025-02-20 Warnings Exact identifier application number: M013 Genexa Acetaminophen PM Extra Strength ACETAMINOPHEN Genexa Inc. d82cf6f3-a291-ca2b-e053-2a95a90a6de1 2025-02-20 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Advagen Pharma Limited 8b9456c9-a56b-4748-adb8-c66d6bf072e8 2025-02-19 Warnings Exact identifier application number: M013 Genexa Childrens Acetaminophen ACETAMINOPHEN Genexa Inc. d89fd9d8-d88e-3968-e053-2a95a90afc5f 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. debfa787-7a48-48b5-94b0-612820524032 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. b16e5dcf-b290-4ff2-a150-4b875647ec9a 2025-02-19 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC bb6533e5-e6a9-488c-b8ab-a6a06e87ede9 2025-02-18 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC c830320e-72ba-48ff-a4cd-250ac5650bf0 2025-02-18 Warnings Exact identifier application number: M013 Aspirina Caplets ASPIRIN Bayer HealthCare LLC. 2e6f5ba8-8e8b-6059-e063-6394a90adcd5 2025-02-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. da7d95af-6583-429d-8d04-e0424f32e9ad 2025-02-17 Warnings Exact identifier application number: M013 GOODYS Mental Alert ASPIRIN AND CAFFEINE Medtech Products Inc. 31ef6d07-d314-4d09-abcd-389ba66cbcc5 2025-02-17 Warnings Exact identifier application number: M013
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 57896-224-01 57896022401 100 TABLET in 1 BOTTLE (57896-224-01) 100 tablet 2024-07-01 0000-00-00 No No Current 57896-224-05 57896022405 50 TABLET in 1 BOTTLE (57896-224-05) 50 tablet 2024-07-01 0000-00-00 No No Current