FDA.reportPublic FDA data

Extra Strenghth Acetaminophen

Product NDC
69517-107
11-digit product format
695170107
Labeler code
69517
Product ID
69517-107_ee149771-a5ff-3af5-e053-2995a90a8d1a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
HealthLife of USA
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-07-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69517-107DDiscontinued by firm2026-10-15
excluded packagepackage69517-10769517-107-05DDiscontinued by firm2026-10-15
excluded packagepackage69517-10769517-107-40DDiscontinued by firm2026-10-15

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct69517-107DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69517-10769517-107-40DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69517-10769517-107-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69517-107-052020-04-07Acetaminophen Extra Strength 500 mg
69517-107-402020-04-07Acetaminophen Extra Strength 500 mg
69517-107-052020-01-31Acetaminophen Extra Strength 500 mg
69517-107-402020-01-31Acetaminophen Extra Strength 500 mg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EEXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJEXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4
TALCINACTIVE INGREDIENT7SEV7J4R1UEXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-107EXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HEALTHLIFE OF USA]13Legacy NDC20231021_e94482ad-c046-4774-97b7-e69befce639b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69517-107-0569517010705500 TABLET in 1 BOTTLE (69517-107-05) 500 tablet2017-07-310000-00-00NoNoCurrent
69517-107-40695170107401 BOTTLE in 1 CARTON (69517-107-40) > 40 TABLET in 1 BOTTLE1 bottle2017-07-310000-00-00NoNoCurrent