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 136 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NightTime SinusACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.0f3b1404-9252-470a-aa8c-b360c85731f32024-11-25WarningsExact identifier
application number: M012
Maximum Strength-Cough and Chest Congestion DMMAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.d1830989-fe82-4f08-8618-78979fcef5682024-11-25WarningsExact identifier
application number: M012
ASP Daytime PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b84f2392-0b24-4af0-80f7-c45454093f512024-11-25WarningsExact identifier
application number: M012
ASP Nighttime MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.d8756d1f-baf5-412d-a493-a1c051eae3022024-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFOODHOLD U.S.A., LLC508a65ee-42fa-4c0b-b24d-9faac6b0eba72024-11-24WarningsExact identifier
application number: M012
DG Day Time Cold and Flu Formula and Night Time Cold and Flu FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLCcb68eef0-b027-4bf1-b78f-f31844a8c06c2024-11-22WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.de2a64ce-c169-4162-b79e-d3809bea21472024-11-22WarningsExact identifier
application number: M012
12 Hour Nasal Decongestant Extra MoisturizingNASAL SPRAYWinCo Foods LLC13fbde45-958c-455f-b766-f6a34342ee952024-11-21WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a01abac3-c13e-40f2-ae98-34bd6c9b75042024-11-21WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c62024-11-21WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.028b025e-2dde-4bef-ba7b-61774e855b4b2024-11-21WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC856cb3c3-8f32-4285-8c13-25f01779a31a2024-11-21WarningsExact identifier
application number: M012
Night Time Severe Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC3375a059-2939-438e-92b5-a7f1952bbb222024-11-21WarningsExact identifier
application number: M012
NiteTime Cold/Flu, Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc9033bf94-f444-4488-b717-050d04dee3882024-11-21WarningsExact identifier
application number: M012
Day and Night Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.4b554ce8-9a6a-444f-b5ea-63359bbc06532024-11-21WarningsExact identifier
application number: M012
Day Severe Cold and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.7492b381-9eca-4b07-b356-63fdaea14f812024-11-21WarningsExact identifier
application number: M012
Severe sinus Congestion ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLCe173bec9-14df-4535-a023-47d8cda8d4ec2024-11-21WarningsExact identifier
application number: M012
COLD FLU and SORE THROAT RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLC1161e5dc-0677-4fb9-964f-971a508098b62024-11-21WarningsExact identifier
application number: M012
Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERetail Business Services, LLCfc8c70d6-6be5-4f12-84b0-125fc82149ec2024-11-21WarningsExact identifier
application number: M012
12 Hour Original Nasal DecongestantNASAL SPRAYWinCo Foods LLCb3b6065a-56da-45e9-b89d-f6553bc181c92024-11-21WarningsExact 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