FDA.reportPublic FDA data

Sunmark pain reliever

Product NDC
49348-042
Requested package NDC
49348-042-14
11-digit product format
493480042
Labeler code
49348
Product ID
49348-042_c323f511-a3b0-419a-aead-ca02ccc5c2c3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2003-08-11
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49348-04249348-042-14DDiscontinued by firm2026-09-14

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 · 2 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 packagepackage49348-04249348-042-14DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-04249348-042-14DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-042-09EA - Each49348-042da709e2b-a470-40ae-9cf3-f25fe793c0f512012-07-24
49348-042-10EA - Each49348-0422406ffab-2650-49cf-9d8c-8bb5fda8d5f312012-07-24
49348-042-14EA - Each49348-04215f80623-8dc1-4b6d-af0d-6c5714292e1712012-07-24
49348-042-19EA - Each49348-042ec091d1c-6dad-4691-894d-5cb620e97fd612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSUNMARK PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MCKESSON]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSUNMARK PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MCKESSON]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSUNMARK PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MCKESSON]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUNMARK PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MCKESSON]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUNMARK PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MCKESSON]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUNMARK PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MCKESSON]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ESUNMARK PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MCKESSON]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSUNMARK PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MCKESSON]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUNMARK PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MCKESSON]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-042SUNMARK PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [STRATEGIC SOURCING SERVICES LLC]8Legacy NDC20241019_8d2e3941-f3c4-4181-871b-3cf6a6cdd3e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-042-1449348004214500 TABLET in 1 BOTTLE (49348-042-14) 500 tablet2003-08-110000-00-00NoNoCurrent