Home NDC 57896-216-01 EXTRA STRENGTH PAIN RELIEVER
Product NDC 57896-216
Requested package NDC 57896-216-01
11-digit product format 578960216
Labeler code 57896
Product ID 57896-216_43cfdcf7-0ae9-3cf5-e063-6294a90a5e7b
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Geri-Care Pharmaceutical Corp
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-02-01
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength 250; 250; 65 mg/1; mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 57896-216 57896-216-01 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 57896-216 57896-216-01 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57896-216 57896-216-01 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
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 PAIN RELIEVER
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 ASPIRIN 250 mg/1 CAFFEINE 65 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup R16CO5Y76E Internal UNII lookup 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308297 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 57896-216-01 EXTRA STRENGTH PAIN RELIEVER 100 in 1 BOTTLE TABLET, FILM COATED 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-216 EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 3 Current NDC, Legacy NDC, 1 package rows 20231020_b670a898-2360-76e2-e053-2a95a90a3380.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 31 of 79 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CareALL Non Aspirin Extra Strength ACETAMINOPHEN New World Imports, Inc da05a1a1-35b4-4787-8c56-12e369f18ff0 2025-12-01 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 80a699b9-bf5c-4765-9e20-ccbc7e3ace7a 2025-12-01 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 66244cdb-2680-4fa8-890d-32aefd490038 2025-12-01 Warnings Exact identifier application number: M013 Family Wellness Childrens Pain Reliever 574 ACETAMINOPHEN Family Dollar Services, Inc. 902c1136-04d2-41f0-81c6-412663cdf378 2025-12-01 Warnings Exact identifier application number: M013 WalgreenChildrens Pain Fever ACETAMINOPHEN WALGREENS CO. 2f757cde-2604-4ca4-b54e-e444f3757cdd 2025-11-26 Warnings Exact identifier application number: M013 Walgreen Childrens Pain plus Fever ACETAMINOPHEN WALGREENS CO. 29ca2855-3c07-435d-a8e1-2997fcedd088 2025-11-26 Warnings Exact identifier application number: M013 Walgreens Childrens Cold plus Cough plus Runny Nose ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE WALGREENS CO. 8714d4e6-3a3b-48c8-8ac1-51b933a2ceac 2025-11-26 Warnings Exact identifier application number: M013 Pain Reliever, 24/7 Life by 7-Eleven ACETAMINOPHEN TABLET, FILM COATED Lil' Drug Store Products, Inc. 44828b89-2563-b233-e063-6294a90ab124 2025-11-26 Warnings Exact identifier application number: M013 MEMBERS MARK ACETAMINOPHEN ACETAMINOPHEN Sam's West Inc 03e831d4-8060-4633-9d02-e77100063fb4 2025-11-26 Warnings Exact identifier application number: M013 Childrens Pain and Fever Dissolve Packs ACETAMINOPHEN WALGREENS CO. ea0f265f-7d64-4731-beda-0bb841dd1ad7 2025-11-25 Warnings Exact identifier application number: M013 Sore Throat Logenzes Sore Throat BENZOCAINE AND MENTHOL ATLANTIC BIOLOGICALS CORP. 71a80e13-bda3-40fb-b4e7-45e9985e707c 2025-11-24 Warnings Exact identifier application number: M013 Low Dose Aspiriun ASPIRIN AMERIFOODS TRADING COMPANY 3802c96a-5e2a-ba9c-e063-6394a90abb78 2025-11-20 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN HYVEE INC 4227aeb1-dd2c-9ca1-e063-6294a90ad709 2025-11-20 Warnings Exact identifier application number: M013 good sense pain relief ACETAMINOPHEN NuCare Pharamceuticals, Inc. 440c13d7-edf0-f611-e063-6394a90af995 2025-11-20 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN HYVEE INC 4227a2cc-69fa-869d-e063-6294a90a1d41 2025-11-20 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN HYVEE INC 422796ed-7558-f7e8-e063-6294a90ad1c7 2025-11-20 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN HYVEE INC 3e61abe4-b4be-01af-e063-6394a90a8b24 2025-11-20 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE HYVEE INC 3e60703b-a5cf-333a-e063-6394a90a2087 2025-11-20 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 54e4ae54-caf8-4105-8428-256f56a2f68f 2025-11-19 Warnings Exact identifier application number: M013 MIDOL COMPLETE ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE R J General Corporation 0c09a178-1a07-4079-b4a6-d1657cb8e714 2025-11-17 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57896-216-01 57896021601 100 TABLET, FILM COATED in 1 BOTTLE (57896-216-01) 2020-02-01 0000-00-00 No No Current