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 35 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)047102c4-3d03-4b2d-961d-0ac75980147b2026-05-06WarningsExact identifier
application number: M012
GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Companyd25f2649-4f8a-4339-8443-faa0b98bdd702026-05-06WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEWinCo Foods, LLC27e911e1-6d22-4a50-8413-1809c8973cbd2026-05-06WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Cough Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51173330-d537-fb9c-e063-6394a90ae3422026-05-05WarningsExact identifier
application number: M012
Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc08e74a8d-8e8d-4cda-9adc-ea2ff40683532026-05-05WarningsExact identifier
application number: M012
GOODSENSE COMBO PACK DAYTIME AND NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companye42f9e0d-f990-4c33-af43-75acf5d776382026-05-05WarningsExact identifier
application number: M012
Rugby Mucus and Chest Congestion 541GUAIFENESINRugby Laboratories76472912-b66f-4bb4-937a-4a589683a78c2026-05-04WarningsExact identifier
application number: M012
Sinus Congestion and Pain Daytime Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEH E Be9dd2d7b-0a19-4a42-b51e-b9914f02406e2026-05-04WarningsExact identifier
application number: M012
Sanatos NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC3dd3ed85-0c0a-8390-e063-6294a90a668e2026-05-04WarningsExact identifier
application number: M012
Good Sense Daytime non drowsy cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company0122cd34-5817-4af5-a51a-8d176dee0a302026-05-04WarningsExact identifier
application number: M012
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafewayd810a6a9-6112-4e9d-a396-36084b7e110e2026-05-04WarningsExact identifier
application number: M012
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8d59d121-62a8-c43b-e053-2a95a90a58472026-05-01WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8e87f8de-f83e-0f8d-e053-2a95a90a8d6a2026-05-01WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8eecb3f0-eb5e-e847-e053-2995a90a86bd2026-05-01WarningsExact identifier
application number: M012
Sinus Pressure and Congestion Relief PE Maximum StrengthPHENYLEPHRINE HCLRite Aid Corporationfccea3c5-42af-4939-82bc-d9409b75f91f2026-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu originalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLCcfaf4b3d-fab4-424d-adbe-aaedca58912d2026-04-30WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLC21e7d323-5b78-43aa-b0fc-34c2a864ab9a2026-04-30WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E Bec0b5f4b-b58c-445f-acf1-c7ce301bba642026-04-30WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLC098428ae-e87d-4c29-8f02-1590530da58e2026-04-29WarningsExact identifier
application number: M012
Panadol Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC341761b9-f0be-f816-e063-6394a90a5e632026-04-29WarningsExact 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