Home NDC 83324-078 Pain Relief
Product NDC 83324-078
11-digit product format 833240078
Labeler code 83324
Product ID 83324-078_458b4f7d-8f0c-2559-e063-6294a90a663b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION, INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-03
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 Pain Relief
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83324-078-01 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 3 83324-078-01 Pain ReliefExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 3 83324-078-05 Pain ReliefExtra Strength 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 3 83324-078-15 Pain ReliefExtra Strength 150 in 1 BOTTLE, PLASTIC TABLET, COATED 150 3 83324-078-24 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 3 83324-078-24 Pain ReliefExtra Strength 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 3 83324-078-50 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 3 83324-078-50 Pain ReliefExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-078 PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.] 2 Current NDC, 8 package rows 20240615_c57c10fc-f182-4153-8974-ef359a5f5ac1.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 72 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Excedrin Tension Headache ACETAMINOPHEN, CAFFEINE Haleon US Holdings LLC 12c074d1-81ac-47d2-8747-b018cda0058a 2024-03-13 Warnings Exact identifier application number: M013 Menstrual Complete ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE Strive Pharmaceuticals Inc. 78c12459-3b27-4ed0-943d-520794eb438d 2024-03-07 Warnings Exact identifier application number: M013 Pain Reliever fever Reducer Extra Strength ACETAMINOPHEN CVS Pharmacy 7b5263ad-01b7-4fc5-9384-4da8efe89e35 2024-03-06 Warnings Exact identifier application number: M013 Excedrin Extra Strength Geltabs ACETAMINOPHEN, ASPRIN, CAFFEINE Haleon US Holdings LLC 11a8439b-0159-4351-b0f5-fe7fad6a33c0 2024-03-05 Warnings Exact identifier application number: M013 Winco Foods Effervescent Pain Relief ASPIRIN Winco Foods, LLC 128afdd7-a9d1-8957-e063-6294a90af569 2024-03-05 Warnings Exact identifier application number: M013 Aspirin Low Dose Safety Coated ASPIRIN Care One (Retail Business Services, LLC.) 6659e103-fa03-4de0-af42-d2fbd548a87c 2024-03-05 Warnings Exact identifier application number: M013 Dolex Children Pain and Fever ACETAMINOPHEN Pharmadel LLC f9158463-aeb1-5de0-e053-6294a90a748b 2024-03-04 Warnings Exact identifier application number: M013 SEDALMEX FORTE ACETAMINOPHEN, ASPIRIN, CAFFEINE Belmora LLC 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d 2024-02-28 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN AMERISOURCE BERGEN 2b923a97-836c-4dac-a8c0-3047a35fb62e 2024-02-23 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL BJWC (Berkley & Jensen / BJ's) b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86 2024-02-22 Warnings Exact identifier application number: M013 M-PAP ACETAMINOPHEN Bryant Ranch Prepack 31a41976-7f65-42d7-acf5-de9c2c5ca58e 2024-02-20 Warnings Exact identifier application number: M013 Publix Fast Relief Effervescent - Original Flavor ASPIRIN PUBLIX SUPER MARKETS INC. 0a342f72-45fd-3e12-e063-6394a90ae33e 2024-02-16 Warnings Exact identifier application number: M013 Equaline Effervescent Pain Reliever ASPIRIN UNITED NATURAL FOODS, INC. DBA UNFI 0761299a-e913-7665-e063-6394a90a6003 2024-02-16 Warnings Exact identifier application number: M013 TopCare Effervescent Pain Relief ASPIRIN TOPCO ASSOCIATES LLC 075f36e1-110c-e839-e063-6294a90a89d7 2024-02-16 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. 115d0b4f-6f0f-79a9-e063-6394a90ab18a 2024-02-14 Warnings Exact identifier application number: M013 PANADOL ACETAMINOPHEN Haleon US Holdings LLC e1799765-c247-42b4-ad6a-8ba7d136abf2 2024-02-06 Warnings Exact identifier application number: M013 Panadol Cold and Flu NonDrowsy ACETAMINOPHEN AND PHENYLEPRINE HCL Haleon US Holdings LLC f626ab17-01c9-4493-ba9e-0c8c11146384 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra ACETAMINOPHEN AND CAFFEINE Haleon US Holdings LLC e5c2d88a-d903-4ca0-b895-f27e791dfc4e 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra Strength ACETAMINOPHEN Haleon US Holdings LLC b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra Strength ACETAMINOPHEN Haleon US Holdings LLC 9d384e88-5c11-4600-ac6c-a38371570138 2024-02-06 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 Sample Exclude flag Status 83324-078-01 83324007801 1 BOTTLE, PLASTIC in 1 CARTON (83324-078-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-03 No No Current 83324-078-05 83324007805 500 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-05) 2024-04-03 No No Current 83324-078-15 83324007815 150 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-15) 2024-04-03 No No Current 83324-078-24 83324007824 1 BOTTLE, PLASTIC in 1 CARTON (83324-078-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-03 No No Current 83324-078-50 83324007850 1 BOTTLE, PLASTIC in 1 CARTON (83324-078-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-03 No No Current