FDA.reportPublic FDA data

Topcare Pain Relief

Product NDC
36800-484
11-digit product format
368000484
Labeler code
36800
Product ID
36800-484_5a603472-0c63-455e-b8a0-53761d1bbdcd
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Topco Associates LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1987-07-15
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
Topcare Pain Relief
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
6036c15b-1168-4103-9471-6a74a2140e53Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-484-47Topcare Pain Relief150 in 1 BOTTLETABLET15014
36800-484-62Topcare Pain Relief24 in 1 BOTTLETABLET2414
36800-484-62Topcare Pain Relief1 in 1 CARTONTABLET114
36800-484-71Topcare Pain Relief50 in 1 BOTTLETABLET5014
36800-484-71Topcare Pain Relief1 in 1 CARTONTABLET114
36800-484-76Topcare Pain Relief1 in 1 CARTONTABLET114
36800-484-76Topcare Pain Relief120 in 1 BOTTLETABLET12014
36800-484-78Topcare Pain Relief100 in 1 BOTTLETABLET10014
36800-484-78Topcare Pain Relief1 in 1 CARTONTABLET114
36800-484-82Topcare Pain Relief100 in 1 BOTTLETABLET10014
36800-484-82Topcare Pain Relief2 in 1 CARTONTABLET214
36800-484-90Topcare Pain Relief500 in 1 BOTTLETABLET50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-484-47EA - Each36800-484ed7befd8-b761-4de8-92fc-b96d3eeaed7c12012-07-24
36800-484-62EA - Each36800-484e4774ec8-04ba-4972-a682-38068c80d70112012-07-24
36800-484-71EA - Each36800-4849599c098-0d18-46b6-8752-60b3accc874312012-07-24
36800-484-78EA - Each36800-4846030322e-462a-486c-b262-24bd54ca039112012-07-24
36800-484-90EA - Each36800-484b5cb19fa-c9b8-4d66-93b1-8efd79af886b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET [TOPCO ASSOCIATES LLC]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET [TOPCO ASSOCIATES LLC]7
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET [TOPCO ASSOCIATES LLC]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET [TOPCO ASSOCIATES LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET [TOPCO ASSOCIATES LLC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET [TOPCO ASSOCIATES LLC]7
POVIDONESINACTIVE INGREDIENTFZ989GH94ETOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET [TOPCO ASSOCIATES LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET [TOPCO ASSOCIATES LLC]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET [TOPCO ASSOCIATES LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-484TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET [TOPCO ASSOCIATES LLC]14Current NDC, Legacy NDC, 12 package rows20241019_6036c15b-1168-4103-9471-6a74a2140e53.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 9 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Low DoseASPIRINARMY AND AIR FORCE EXCHANGE SERVICEe273ead7-7cbc-4fd5-a136-9d3558a353602026-06-24WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENCVS PHARMACY5e35df92-6282-4ca6-902b-bb6bd326b4872026-06-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENOrelli Inc.4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d2026-06-22WarningsExact identifier
application number: M013
Pain Relief Aspirin Chewable, Low DoseASPIRINRite Aid Corporation65cdce0f-be04-43ba-8c68-bdce7983cfa12026-06-22WarningsExact identifier
application number: M013
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leader88f425df-712d-4911-824b-94085c7190b62026-06-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINMeijer Distribution, Inc.3716a7d4-a555-4e54-aa0a-7b8f3e32addb2026-06-19WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDOLGENCORP, LLCacc94a3e-21b6-4375-9881-38cf9bab86922026-06-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINL.N.K. International, Inc.2f6ec676-3832-420e-be91-fce83f6586c82026-06-19WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEDOLGENCORP, LLCe1e24d52-0b4d-400b-8181-e3f6ab75c4f62026-06-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENOncor Pharmaceuticals4c396d0e-aa93-4f9e-b065-2e606f7f05cd2026-06-17WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINFamora Inc.4dc6f119-bbde-db5f-e063-6294a90a94862026-06-16WarningsExact identifier
application number: M013
Childrens Pain and Fever ReliefACETAMINOPHENChain Drug Marketing Association, Inc.420a1e05-caa6-481f-bdab-a670f0220f962026-06-16WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDOLGENCORP, LLCce9f4e0d-43fb-499a-b8a2-a997a14841c42026-06-16WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENL.N.K. International, Inc.734cc3d2-6fc5-4dcc-93ed-0b57c1f013452026-06-15WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d63671d-cf7c-bbdd-e063-6294a90affef2026-06-15WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC59773893-09a8-47a2-943a-e9ea9da4458a2026-06-15WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENShield Pharmaceuticals Corp.96eb7f9f-ff2d-4661-bbe6-1860aafe03f62026-06-15WarningsExact identifier
application number: M013
Duralgina Extra StrengthACETAMINOPHENMenper Distributors, Inc.544e3d7e-a759-384f-e063-6294a90a5baa2026-06-15WarningsExact identifier
application number: M013
pain relief childrensACETAMINOPHENRite Aid Corporationbe2286a1-946b-4bf5-b14c-8e86da6695942026-06-15WarningsExact identifier
application number: M013
Aspirin 81ASPIRINAmerisource Bergen4491faca-f30b-4eb0-bea9-f518f6b2f0952026-06-15WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN6036c15b-1168-4103-9471-6a74a2140e5314
198440acetaminophen 500 MG Oral TabletSCD6036c15b-1168-4103-9471-6a74a2140e5314
198440APAP 500 MG Oral TabletSY6036c15b-1168-4103-9471-6a74a2140e5314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-484-4736800048447150 TABLET in 1 BOTTLE (36800-484-47) 150 tablet1987-07-150000-00-00NoNoCurrent
36800-484-62368000484621 BOTTLE in 1 CARTON (36800-484-62) / 24 TABLET in 1 BOTTLE1 bottle1987-07-150000-00-00NoNoCurrent
36800-484-71368000484711 BOTTLE in 1 CARTON (36800-484-71) / 50 TABLET in 1 BOTTLE1 bottle1987-07-150000-00-00NoNoCurrent
36800-484-76368000484761 BOTTLE in 1 CARTON (36800-484-76) / 120 TABLET in 1 BOTTLE1 bottle1987-07-150000-00-00NoNoCurrent
36800-484-78368000484781 BOTTLE in 1 CARTON (36800-484-78) / 100 TABLET in 1 BOTTLE1 bottle1987-07-150000-00-00NoNoCurrent
36800-484-82368000484822 BOTTLE in 1 CARTON (36800-484-82) / 100 TABLET in 1 BOTTLE2 bottle1987-07-150000-00-00NoNoCurrent
36800-484-9036800048490500 TABLET in 1 BOTTLE (36800-484-90) 500 tablet1987-07-150000-00-00NoNoCurrent