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…
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 1 of 85 · 1,689 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Childrens Pain plus Fever Relief ACETAMINOPHEN CVS PHARMACY e4cbfb06-d826-4d08-95d6-60305c417625 2026-08-14 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN CVS Pharmacy,Inc. 3738d35c-1e83-40df-9292-c54e6b2c8353 2026-08-14 Warnings Exact identifier application number: M013 CVS Childrens Pain plus Fever Relief ACETAMINOPHEN CVS PHARMACY 22a48a33-995b-481e-9e4e-1ad7ec346f44 2026-08-14 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN Topco Associates, LLC 8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101 2026-08-12 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN HARRIS TEETER 54e69d5a-55d7-4ebe-8494-0be93613f1e2 2026-08-12 Warnings Exact identifier application number: M013 Chewable Aspirin ASPIRIN HARRIS TEETER c6a28c83-60c9-3304-e053-2a95a90aa06c 2026-08-12 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN HARRIS TEETER 93cbd3cb-1072-89e6-e053-2995a90a2f15 2026-08-12 Warnings Exact identifier application number: M013 Adult Chewable Aspirin ASPIRIN HARRIS TEETER c6a28617-1769-7a7d-e053-2995a90a1ea0 2026-08-12 Warnings Exact identifier application number: M013 Gencare- Pain Relief Acetaminophen ACETAMINOPHEN Pioneer Life Sciences, LLC 2111c91b-2fd7-4ab3-946a-d4e0cf46399a 2026-08-12 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN Salado Sales, Inc. 1dbd8480-5cb4-4577-9091-b2a2add4f1af 2026-08-12 Warnings Exact identifier application number: M013 pain relief childrens ACETAMINOPHEN Rite Aid Corporation 29ecdd2d-aeaf-40a8-a347-011088009ea6 2026-08-11 Warnings Exact identifier application number: M013 Fast Acting Pedia Crae ACETAMINOPHEN Randob Labs., Ltd. e069060f-fbb2-4c7a-b872-00b3ab86d01b 2026-08-11 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN Amazon.com Services LLC c7cc0681-4c0b-4565-99df-d0168c8ba1ba 2026-08-10 Warnings Exact identifier application number: M013 GenCare Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Pioneer Life Sciences, LLC ac8c4bdf-30c9-2b09-e053-2a95a90a9b67 2026-08-09 Warnings Exact identifier application number: M013 Gencare-Aspirin Low Dose Pain reliever (NSAID) ASPIRIN Pioneer Life Sciences, LLC 24d4f46a-c7a5-4e94-804f-1e307d8e8cfc 2026-08-09 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN DOLGENCORP, LLC b4064039-2345-4227-b83d-54dc13a838d3 2026-08-07 Warnings Exact identifier application number: M013 berkley and jensen acetaminophen ACETAMINOPHEN BJWC dee57d73-73ac-48bb-b1da-9971f1ff21c4 2026-08-07 Warnings Exact identifier application number: M013 Aspirin ASPIRIN P & L Development, LLC 4cd74cec-a209-4e92-b853-fbe5c95f7678 2026-08-06 Warnings Exact identifier application number: M013 Tension Headache Aspirin-Free ACETAMINOPHEN, CAFFEINE Rite Aid Corporation 093a7c26-f2b1-4416-b193-81133d247d2e 2026-08-06 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Kroger Company bc17b2e5-4828-6a2e-e053-2995a90a8c63 2026-08-05 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