Home NDC 36800-991 Pain Relief
Product NDC 36800-991
11-digit product format 368000991
Labeler code 36800
Product ID 36800-991_44608f7f-377f-4006-9c9e-d154e3a45e10
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Topco Associates, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-01-30
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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
Listing expiration 2027-12-31 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 36800-991-06 Pain Relief 200 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 200 10 36800-991-15 Pain Relief 1 in 1 CARTON TABLET, FILM COATED 1 10 36800-991-15 Pain Relief 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-991 PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC] 9 Current NDC, Legacy NDC, 3 package rows 20240723_8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101.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 56 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Publix Fast Relief Effervescent ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Publix Super Markets Inc. 73051f16-2569-7394-e053-2991aa0a5359 2024-11-13 Warnings Exact identifier application number: M013 Quality Choice Effervescent Antacid and Pain Relief ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 70d265de-ff94-e0e4-e053-2a91aa0a962a 2024-11-13 Warnings Exact identifier application number: M013 Quality Choice Extra Strength Effervescent Antacid and Pain Relief ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 9f7d0c96-a561-a8a0-e053-2995a90a250b 2024-11-13 Warnings Exact identifier application number: M013 WinCo Foods Effervescent Antacid and Pain Relief ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET WinCo Foods, LLC 0c8a755a-089f-477f-97e9-0dd6fdfbe99d 2024-11-13 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Kroger Company 8fb19444-f0e0-4d26-81e8-6a4b835056d8 2024-11-12 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN WALMART INC. 59d01f72-4575-48e2-b914-b6a6456ca7d2 2024-11-11 Warnings Exact identifier application number: M013 pain and fever ACETAMINOPHEN Kroger Company d181560c-1c39-4f2e-8a17-996224ca040f 2024-11-09 Warnings Exact identifier application number: M013 Childrens Tylenol ACETAMINOPHEN Kenvue Brands LLC babcb210-6a47-46ef-b4ea-bdde80411cd3 2024-11-08 Warnings Exact identifier application number: M013 Bayer Genuine Aspirin ASPIRIN Acme United Corporation f7f9dc46-a945-7ae3-e053-6394a90a1192 2024-11-08 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC dd87e342-b0cb-4111-9f15-415dbcda4b77 2024-11-07 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 0c5fdda8-5049-46de-e063-6294a90a592b 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 46ddbfde-54ab-4373-b832-b9c0620b1e9d 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 333f6231-3778-4c1f-9558-2afddca22c86 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 34247a3b-0846-4086-becd-76e630b3b721 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC a51c2deb-c703-4dc8-9255-8ac9fe635170 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC ce0a1fbc-7345-462b-b0da-c7149bdc288c 2024-11-07 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC 015a6179-bacb-452d-b594-4de628ddc11d 2024-11-07 Warnings Exact identifier application number: M013 TYLENOL Regular Strength ACETAMINOPHEN Kenvue Brands LLC de5c6654-56c5-40d3-a286-f04ed47ac7c8 2024-11-07 Warnings Exact identifier application number: M013 Midol Complete ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE Acme United Corporation f7bf126d-a6f1-231a-e053-6294a90a04e1 2024-11-07 Warnings Exact identifier application number: M013 CareOne Childrens Acetaminophen ACETAMINOPHEN American Sales Company 49021ae8-9655-4885-9f74-52df4cdcb26f 2024-11-07 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 36800-991-06 36800099106 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (36800-991-06) 2019-01-30 2022-09-02 No No Current 36800-991-15 36800099115 1 BOTTLE, PLASTIC in 1 CARTON (36800-991-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2019-01-30 0000-00-00 No No Current