FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-99136800-991-06DDiscontinued by firm2026-10-21

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-991-06Pain Relief200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20010
36800-991-15Pain Relief1 in 1 CARTONTABLET, FILM COATED110
36800-991-15Pain Relief50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-991PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]9Current NDC, Legacy NDC, 3 package rows20240723_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 79 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWestminster Pharmaceuticals, LLCace5ebac-ec11-4c26-b1e3-954b450ee6712021-05-04WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health8cacf02c-9925-40d4-92bc-78788aa0681a2020-11-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHEN 500 MGAllegiant Health8e60b78e-ef3c-4d44-b8d4-37cb8608a5c72020-03-13WarningsExact identifier
application number: M013
Acetaminophen 500mg ESACETAMINOPHEN 500MGAllegiant Health91acc132-01b6-467b-9af5-70f4dc93e0872019-01-08WarningsExact identifier
application number: M013
Acetaminophen 325mg RSACETAMINOPHEN 325MGAllegiant Health61c6d281-e59b-4277-bbce-f71c12c2a56d2019-01-07WarningsExact identifier
application number: M013
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAllegiant Health9a4c0c43-a71a-4e22-a3d5-9eb9622689a22019-01-02WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MGAllegiant Health423a8445-964c-4cdb-889a-f391ca5253e72018-12-31WarningsExact identifier
application number: M013
Cold Multi-Symptom Night-timeACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCIAllegiant Health3f020cf2-6011-4216-9b39-0b3dc5f0749c2018-12-26WarningsExact identifier
application number: M013
Aspirin ChewableASPIRIN 81 MGAllegiant Health92b8637b-03a9-461f-b2f6-6eddaa2149532018-12-21WarningsExact identifier
application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-DrowsyACETAMINOPHEN AND PHENYLEPHRINE HCLAllegiant Healthb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f2018-12-21WarningsExact identifier
application number: M013
Clear Choice Regular Strength Pain RelieverACETAMINOPHENAthlete's Needs, Inc.d0d9fda5-5eba-4d51-b505-e93a2ae0bdd72018-12-11WarningsExact identifier
application number: M013
ASPIRIN Enteric CoatedASPIRIN 81 MGAllegiant Health5910a882-eb40-440f-8a30-c21fbce9050e2018-11-07WarningsExact identifier
application number: M013
AspirinASPIRIN 325 MGAllegiant Health88b54062-8b3d-4024-a957-62b3255184b92018-11-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe52018-11-07WarningsExact identifier
application number: M013
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Healthb431a1a3-39c4-4d6c-afdc-c8b017ad89da2017-11-16WarningsExact identifier
application number: M013
SED-MAXACETAMINOPHEN 500 MG WITH CAFFEINE 65MGCommand Brands, LLC4920a0e9-6f88-4df0-8657-77c95a3b96172017-01-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN8b9e90da-98e2-4d8d-bf6e-54b0a8f8d10110
198440acetaminophen 500 MG Oral TabletSCD8b9e90da-98e2-4d8d-bf6e-54b0a8f8d10110
198440APAP 500 MG Oral TabletSY8b9e90da-98e2-4d8d-bf6e-54b0a8f8d10110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-991-0636800099106200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (36800-991-06) 2019-01-302022-09-02NoNoCurrent
36800-991-15368000991151 BOTTLE, PLASTIC in 1 CARTON (36800-991-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2019-01-300000-00-00NoNoCurrent