FDA.reportPublic FDA data

Acetaminophen Extra Strength

Product NDC
58602-745
11-digit product format
586020745
Labeler code
58602
Product ID
58602-745_0b44d6cf-d21e-741a-e063-6294a90a05ff
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-07
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
Acetaminophen 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc03fa56-8880-4bbd-81a0-91853fecdd4eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-745-07Acetaminophen Extra Strength24 in 1 BOTTLETABLET242
58602-745-07Acetaminophen Extra Strength1 in 1 CARTONTABLET12
58602-745-14Acetaminophen Extra Strength50 in 1 BOTTLETABLET502
58602-745-14Acetaminophen Extra Strength1 in 1 CARTONTABLET12
58602-745-21Acetaminophen Extra Strength100 in 1 BOTTLETABLET1002
58602-745-21Acetaminophen Extra Strength1 in 1 CARTONTABLET12
58602-745-35Acetaminophen Extra Strength225 in 1 BOTTLETABLET2252
58602-745-35Acetaminophen Extra Strength1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-745ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [AUROHEALTH LLC]2Current NDC, Legacy NDC, 8 package rows20231130_bc03fa56-8880-4bbd-81a0-91853fecdd4e.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 60 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adult Low Strength AspirinASPIRINDISCOUNT DRUG MART9196e6de-432a-4f1c-b09b-226e4717c87c2024-10-17WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI1462b308-a6a5-49ca-ab29-cacbf62caf0b2024-10-17WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf3db8598-fe0e-4c53-a023-5f5f8f002cc62024-10-17WarningsExact identifier
application number: M013
acetaminophen pm extra strengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIf86a11af-6d3c-4638-870d-a663ddf493712024-10-17WarningsExact identifier
application number: M013
Acetaminophen Gelcaps Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI3588a3ef-a493-43ed-96e0-c259f0d087db2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLCa2186895-944b-48cb-b3c2-eac208866c342024-10-17WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC6a5d43c8-f4b7-4447-b2e1-53eb12208ef02024-10-17WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC32cc6e05-84c1-4710-bebc-cb6e7133dc542024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC2ca87a29-1f54-4da4-a66f-3b3dd4f0396c2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e2024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINKroger Company453f62d5-f580-4d19-bfae-4f78c2a6b6d62024-10-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA Store Inc.ec6add55-f4a3-7818-e053-2a95a90aee042024-10-16WarningsExact identifier
application number: M013
ASPIRINASPIRINFSA Store Inc.062e7b7b-d052-82b0-e063-6294a90a7cce2024-10-16WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.f4322f34-ac19-371e-e053-2a95a90ac8642024-10-16WarningsExact identifier
application number: M013
Low dose Chewable AspirinASPIRINFSA STORE INC.f939b44c-93b6-ca61-e053-6394a90ae5862024-10-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART850b5ad8-8774-413c-ae38-022215a94f952024-10-16WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINDISCOUNT DRUG MARTaf0f50d2-3e2d-f723-e053-2995a90a0d4b2024-10-16WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINDISCOUNT DRUG MART03ed19dd-1cfc-47d5-b83e-ffa2ebe93f482024-10-16WarningsExact identifier
application number: M013
365 whole foods market acetaminophenACETAMINOPHENWhole Foods Market, INC.57f89574-98e5-40e5-8dd4-e868a668adaa2024-10-15WarningsExact identifier
application number: M013
PAIN RELIEF Regular StrengthACETAMINOPHENAMERICAN SALES COMPANY2e3eabc8-193b-4397-a43c-db838eb16e672024-10-15WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-745-07586020745071 BOTTLE in 1 CARTON (58602-745-07) / 24 TABLET in 1 BOTTLE1 bottle2021-01-070000-00-00NoNoCurrent
58602-745-14586020745141 BOTTLE in 1 CARTON (58602-745-14) / 50 TABLET in 1 BOTTLE1 bottle2021-01-070000-00-00NoNoCurrent
58602-745-21586020745211 BOTTLE in 1 CARTON (58602-745-21) / 100 TABLET in 1 BOTTLE1 bottle2021-01-070000-00-00NoNoCurrent
58602-745-35586020745351 BOTTLE in 1 CARTON (58602-745-35) / 225 TABLET in 1 BOTTLE1 bottle2021-01-070000-00-00NoNoCurrent