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 22 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYLENOL Regular Strength ACETAMINOPHEN Kenvue Brands LLC 01f41fae-4abb-4b96-ab09-a7d3dfc286cd 2026-01-26 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN Meijer Distribution Inc ec4dbb71-b507-42a3-9b68-14d4b6621ec1 2026-01-23 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs 9105eff0-1c22-4298-8ee5-9fb7a1de12f1 2026-01-23 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Preferred Pharmaceuticals Inc. c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e 2026-01-22 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 17cfa99d-abb2-4d77-9e0e-e77109fbb61a 2026-01-21 Warnings Exact identifier application number: M013 Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MG Farmacias De Similares TX LLC 48ea0a2c-511b-4805-e063-6394a90a1225 2026-01-21 Warnings Exact identifier application number: M013 childrens mapap ACETAMINOPHEN Major Pharmaceuticals a1b0ccf0-cf24-4b34-b42a-aa1cc1e57f60 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN WALGREENS CO. 9b756e4e-6c56-43aa-a5bc-5b649440e759 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH PAIN RELIEVER PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WALGREENS CO. 5a58d620-a0ec-48d7-92dd-3f3f78ec10ea 2026-01-20 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN Wal-Mart Stores Inc d4e438c6-80dd-4531-91e6-bc4ca7a8570f 2026-01-20 Warnings Exact identifier application number: M013 Unishield Extra Strength Non-Aspirin ACETAMINOPHEN Unishield ba0ec1eb-db85-6a7f-e053-2995a90aafe5 2026-01-19 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN HyVee Inc 24acd62f-72b1-418a-b733-7e4888f3c0a3 2026-01-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Cardinal Health 110, LLC. DBA Leader dd8b13a5-07df-4cec-92c3-1a662b1e1a56 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 7d8f8389-730d-494e-a0af-5a91a3c99e17 2026-01-16 Warnings Exact identifier application number: M013 TENSION HEADACHE RELIEF ACETAMINOPHEN AND CAFFEINE WALGREENS 54aff6a0-2778-472f-90ba-375d6bce6ee8 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 097fbab7-3886-4e75-b037-f03adcf3859f 2026-01-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS CO. bdb09e15-8e17-4987-99d0-bab8856a2109 2026-01-16 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN HF Acquisition Co LLC, DBA HealthFirst 4870ff00-f727-814d-e063-6394a90a6c8e 2026-01-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN HyVee Inc 957b13a4-4086-459f-8fa0-9708b317fabe 2026-01-15 Warnings Exact identifier application number: M013 Unisom PM Pain Nighttime Sleep Aid and Pain Reliever ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Chattem, Inc. 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb 2026-01-14 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