ACTIDOGESIC

Product NDC
63102-402
11-digit product format
631020402
Labeler code
63102
Product ID
63102-402_abf1349b-a08e-4236-9b32-42a0e76e78a9
Type
HUMAN OTC DRUG
Nonproprietary name
Dexbrompheniramine maleate, acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
ACTIPHARMA, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-14
Substance
ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active strength
500; 1 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACTIDOGESIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DEXBROMPHENIRAMINE MALEATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, BPA9UT29BS
Rxcui1798453

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63102-402-102024-08-06C16284748780-10191ceaa-6363-198a-e063-dbdaa90aec3eACTIDOGESIC ®
63102-402-102023-07-28C16284748780-10191ceaa-6363-198a-e063-dbdaa90aec3eACTIDOGESIC ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-402-10ACTIDOGESIC100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63102-402-10EA - Each63102-4027639ce03-04bd-412d-bb24-439b7f9419c412017-03-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletPSN697da3f9-9888-4d41-ba83-87ca9bf1e54b5
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletSCD697da3f9-9888-4d41-ba83-87ca9bf1e54b5
1798453APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral TabletSY697da3f9-9888-4d41-ba83-87ca9bf1e54b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63102-402-1063102040210100 TABLET in 1 BOTTLE (63102-402-10) 100 tablet2016-10-140000-00-00NoNoCurrent