FDA.reportPublic FDA data

ACTIDOGESIC DF

Product NDC
63102-403
11-digit product format
631020403
Labeler code
63102
Product ID
63102-403_d024a896-b400-4d33-a6aa-9643f823d4e2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dexbrompheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
ACTIPHARMA, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-10
Substance
ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active strength
500; 1 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
ACTIDOGESIC DF
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
BPA9UT29BSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1798453Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff8e2565-bce3-4c06-a416-6e8f369f057fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63102-403-102023-10-10C16284748780-10191ceaa-66bf-198a-e063-dbdaa90aec3eACTIDOGESIC ® - DF
63102-403-102023-07-28C16284748780-10191ceaa-66bf-198a-e063-dbdaa90aec3eACTIDOGESIC ® - DF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-403-10ACTIDOGESIC DF100 in 1 BOTTLE, PLASTICTABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63102-403-10EA - Each63102-40359498c56-383c-4e13-b4c5-59f017cfa6da12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63102-403ACTIDOGESIC DF (ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE) TABLET [ACTIPHARMA, LLC]4Current NDC, Legacy NDC, 1 package rows20240809_ff8e2565-bce3-4c06-a416-6e8f369f057f.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 106 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique ChlorphenCHLORPHENIRAMINE MALEATEUnifirst First Aid Corporationb3d5d161-8d4c-f1bb-e053-2a95a90a5bc52025-09-08WarningsExact identifier
application number: M012
Crane Safety Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDECrane Safety LLC968baa85-ce0e-0c3d-e053-2995a90ac03a2025-09-08WarningsExact identifier
application number: M012
Thompson Cherry Cough DropsMENTHOLThompson Safety LLCc948f5b0-8491-6f9f-e053-2995a90a55fa2025-09-08WarningsExact identifier
application number: M012
Medique Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione64c283b-0efa-0bfd-e053-2a95a90ab71d2025-09-08WarningsExact identifier
application number: M012
Daytime Nighttime Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATEWalgreensa99fdd49-0160-4a82-983b-fa56ab38ae762025-09-08WarningsExact identifier
application number: M012
Dye Free Wal Dryl Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEWalgreens53e6f72d-15a4-4efe-8b1f-5753fed53df82025-09-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreens40bfd631-51a4-4684-9ba0-a365d61da9bc2025-09-08WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensf796ce1f-3077-4a0d-a41a-249c345ddb5f2025-09-08WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc6ccbd537-2264-4b3c-804e-3d3ea5368a5f2025-09-05WarningsExact identifier
application number: M012
Ephedrine SulfateEPHEDRINE SULFATEWalgreen Companydc0072f9-7111-1af0-e053-2a95a90aed562025-09-04WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBrACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS Pharmacy, Inc31aa77e0-cfdb-57a8-e063-6394a90af98c2025-09-04WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATECVS Pharmacy, Inc.4bb70a55-de44-3dc1-e054-00144ff8d46c2025-09-04WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATECVS PHARMACYa645b31e-7da7-4fe6-a04f-ac794ef524942025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de637b1-3402-db86-e063-6294a90ac9812025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CMedical Group Care LLCf4a9cfec-0725-8f4a-e053-2995a90a1b4a2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de65c99-6c2d-3650-e063-6394a90aa98c2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREEMedical Group Care LLCf4a9d879-4736-4f63-e053-2995a90adeba2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de66240-441c-00ad-e063-6294a90a4a052025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CMedical Group Care LLCff99c57a-e06a-69d3-e053-6394a90a67752025-09-03WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de7ace0-e389-b751-e063-6394a90ab4e92025-09-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletPSNff8e2565-bce3-4c06-a416-6e8f369f057f5
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletSCDff8e2565-bce3-4c06-a416-6e8f369f057f5
1798453APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral TabletSYff8e2565-bce3-4c06-a416-6e8f369f057f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63102-403-1063102040310100 TABLET in 1 BOTTLE, PLASTIC (63102-403-10) 100 tablet2020-07-100000-00-00NoNoCurrent