Pain Relief

Product NDC
36800-770
11-digit product format
368000770
Labeler code
36800
Product ID
36800-770_286014c1-2183-fc25-e063-6394a90aa15e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TopCo Associates LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-31
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-77036800-770-01DDiscontinued by firm2026-10-16
excluded packagepackage36800-77036800-770-03DDiscontinued by firm2026-10-16
excluded packagepackage36800-77036800-770-05DDiscontinued by firm2026-10-16
excluded packagepackage36800-77036800-770-12DDiscontinued by firm2026-10-16

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0536800-770-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0536800-770-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0536800-770-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0536800-770-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2636800-770-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2636800-770-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2636800-770-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2636800-770-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3136800-770-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3136800-770-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3136800-770-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3136800-770-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2836800-770-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2836800-770-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2836800-770-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2836800-770-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2136800-770-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2136800-770-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2136800-770-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2136800-770-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1036800-770-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1036800-770-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1036800-770-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1036800-770-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3136800-770-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3136800-770-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3136800-770-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3136800-770-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2036800-770-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2036800-770-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2036800-770-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2036800-770-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1036800-770-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1036800-770-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1036800-770-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1036800-770-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0836800-770-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0836800-770-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0836800-770-12ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0836800-770-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0336800-770-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0336800-770-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0336800-770-12367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0336800-770-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0936800-770-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0936800-770-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0936800-770-12557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0936800-770-01557ba5c1ecfa…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
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

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
ecd6df7e-e7e2-446b-85ef-25971281fe31Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-770-01Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED17
36800-770-01Pain ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED247
36800-770-02Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED17
36800-770-02Pain ReliefExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED507
36800-770-03Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1007
36800-770-03Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED17
36800-770-05Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED17
36800-770-05Pain ReliefExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED2257
36800-770-12Pain ReliefExtra Strength400 in 1 BOTTLE, PLASTICTABLET, COATED4007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-770PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 9 package rows20241206_ecd6df7e-e7e2-446b-85ef-25971281fe31.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 48 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mgASPIRINAsclemed USA, Inc.878dab20-668b-4d7a-a5f8-794a587564d52025-02-13WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCVS HEALTH CORPbbc48c9e-7eb8-2c67-e053-2a95a90a85522025-02-13WarningsExact identifier
application number: M013
Dye Free Infants Pain and FeverACETAMINOPHENCVS1fde0f7c-4b5b-ae9c-e063-6394a90afa412025-02-13WarningsExact identifier
application number: M013
NOTTS - Extra Strength 500 mgACETAMINOPHENVIVUNT PHARMA LLCe677f43d-b4ce-e5b0-e053-2a95a90ad67e2025-02-12WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINELEADER/ Cardinal Health 110, Inc.b3773f02-02a9-33c8-e053-2995a90a22352025-02-11WarningsExact identifier
application number: M013
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC.c9f80d24-bd05-e1ce-e053-2995a90aa6462025-02-10WarningsExact identifier
application number: M013
Low dose AspirinASPIRIN 81 MG DELAYED RELEASE TABLETSWALGREENSc25c55aa-9932-0a55-e053-2a95a90a3d1e2025-02-10WarningsExact identifier
application number: M013
AeroTab Pain RelieverPAIN RELIEVERAero Healthcare40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f2025-02-10WarningsExact identifier
application number: M013
Enteric Coated Aspirin Regular StrengthASPIRINTime-Cap Labs, Inc5fbd8bb3-46f9-4089-9a21-b6af97a061062025-02-08WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENTIME CAP LABS INCc193dbc0-cc80-4a7c-aa29-457a20edf8352025-02-08WarningsExact identifier
application number: M013
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.22f23aeb-f874-6e54-e063-6394a90a95652025-02-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3008928-c555-64ad-e053-2995a90a73072025-02-05WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINBETTER LIVING BRANDS LLC.f300dfbc-7137-79d1-e053-2995a90a636e2025-02-05WarningsExact identifier
application number: M013
Low dose aspirin 81mgASPIRINBETTER LIVING BRANDS LLC.f300c30b-ab1a-a1b4-e053-2a95a90a12942025-02-05WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC5d174187-cf89-41ff-9a64-10e0276daf172025-02-05WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENBryant Ranch Prepackc226205d-7c3c-49af-b3e2-fc7b09ad78572025-02-05WarningsExact identifier
application number: M013
Dye Free Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmaa69fca9d-c0a0-4321-bf03-5c8e99cc07cc2025-02-04WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN-CAFFEINETARGET CORPORATION8ed1679d-d3a1-11b1-e053-2995a90a61ad2025-01-31WarningsExact identifier
application number: M013
ValuMeds Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINECabinet Health P.B.C.0f864e73-e4b8-4e23-8990-8439ac17bd582025-01-31WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN TABLETS 500 MGWALGREENSc25bfe92-0196-0489-e053-2995a90abea12025-01-30WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNecd6df7e-e7e2-446b-85ef-25971281fe317
198440acetaminophen 500 MG Oral TabletSCDecd6df7e-e7e2-446b-85ef-25971281fe317
198440APAP 500 MG Oral TabletSYecd6df7e-e7e2-446b-85ef-25971281fe317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-770-01368000770011 BOTTLE, PLASTIC in 1 CARTON (36800-770-01) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC2014-03-310000-00-00NoNoCurrent
36800-770-02368000770021 BOTTLE, PLASTIC in 1 CARTON (36800-770-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2014-03-310000-00-00NoNoCurrent
36800-770-03368000770031 BOTTLE, PLASTIC in 1 CARTON (36800-770-03) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC2014-03-310000-00-00NoNoCurrent
36800-770-05368000770051 BOTTLE, PLASTIC in 1 CARTON (36800-770-05) > 225 TABLET, COATED in 1 BOTTLE, PLASTIC2014-03-312022-09-30NoNoCurrent
36800-770-1236800077012400 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-770-12) 2016-01-012022-03-31NoNoCurrent