Pain Reliever Rapid Release

Product NDC
49348-116
11-digit product format
493480116
Labeler code
49348
Product ID
49348-116_e9475408-2f62-53ab-e053-2995a90a402a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-10-24
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49348-116DDiscontinued by firm2026-10-05
excluded packagepackage49348-11649348-116-10DDiscontinued by firm2026-10-05

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-116-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-116-10f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-116-10EA - Each49348-116eb7e50cb-ac91-460b-ac52-0998c5ef114712015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
GELATININACTIVE INGREDIENT2G86QN327LPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEVER RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [MCKESSON]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49348-116-10493480116101 BOTTLE, PLASTIC in 1 CARTON (49348-116-10) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC2014-10-240000-00-00NoNoCurrent