FDA.reportPublic FDA data

Activcin

Product NDC
69729-008
11-digit product format
697290008
Labeler code
69729
Product ID
69729-008_155f6c02-531c-c2bc-e063-6294a90a270f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
OPMX LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-23
Substance
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 325; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Activcin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
362O9ITL9DInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086997Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e06a4d72-cc8d-fd9d-e053-2995a90a7a76Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-008-10Activcin1 in 1 CARTONCAPSULE, LIQUID FILLED14
69729-008-10Activcin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-008ACTIVCIN (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [OPMX LLC.]4Current NDC, Legacy NDC, 2 package rows20240407_e06a4d72-cc8d-fd9d-e053-2995a90a7a76.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 79 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and Flu Relief, 24-7 Life BY 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.2771d699-3f70-4318-e063-6394a90a89cc2025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b2025-12-09WarningsExact identifier
application number: M012
Circle K Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc9a32bc6d-0499-48fa-a6ad-702c8a28bf5f2025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp5015a380-a229-4eff-8e31-528065c6ed642025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teetercaf59320-5b48-4533-bda9-7b03a2fde0b52025-12-09WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC30d41dc3-e2ef-4cad-b63c-d634bc749aa12025-12-09WarningsExact identifier
application number: M012
Walgreens Childrens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company327a7226-84b9-26d7-e063-6394a90a99b92025-12-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR AND GUAIFENESINMeijer Distribution Inc8ed5b802-a26e-45b4-a696-bc64dbac47332025-12-09WarningsExact identifier
application number: M012
dg health cold plus flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCff4a2f0a-d638-4ed2-8e05-2a52afbc49092025-12-09WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)24894484-b834-4b2f-b365-c95b5e30d8bf2025-12-09WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEFamily Dollar (FAMILY WELLNESS)2c431220-c61b-4ad5-9ad2-58ccaee2d1c32025-12-09WarningsExact identifier
application number: M012
Sinus PE Congestion Daytime NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLMeijer Distribution, Inc.9da77306-5098-4c79-845c-97ead849c84a2025-12-08WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fdd0dadc-5313-4f6e-aef5-ca853efe5c4d2025-12-08WarningsExact identifier
application number: M012
MucolyteGUAIFENESINRising Pharma Holdings, Inc.e4091aaf-44e3-4701-9986-aff248a2f1b82025-12-08WarningsExact identifier
application number: M012
Mucolyte DMGUAIFENESIN, DEXTROMETHORPHAN HBRRising Pharma Holdings, Inc.c913d27d-bc00-4ace-9a5f-c55522e1cd1d2025-12-08WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLAmerican Sales47f504d5-3ec5-5227-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Menthol Cough DropsMENTHOLAmerican Sales4893ac0a-7769-5657-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLAmerican Sales45e891ea-2f2a-31b7-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINEAmerican Sales49248a40-1ca3-6dd1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLAmerican Sales4896cbd1-57dd-1fc6-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNe06a4d72-cc8d-fd9d-e053-2995a90a7a764
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDe06a4d72-cc8d-fd9d-e053-2995a90a7a764
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYe06a4d72-cc8d-fd9d-e053-2995a90a7a764

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-008-10697290008101 BLISTER PACK in 1 CARTON (69729-008-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2022-05-230000-00-00NoNoCurrent