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 172 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDeMoulas Market Baskete92d2f64-9690-42d3-b787-cafade3a89992023-12-29WarningsExact identifier
application number: M012
Cold and Sinus Maxium StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basket6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2023-12-29WarningsExact identifier
application number: M012
Cold, Flu and Sore Throat Maxium StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketd98029c0-ccd9-47e1-996f-c7786cd4ecca2023-12-29WarningsExact identifier
application number: M012
MAXIMUM STRENGTH Sinus ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC0f2be061-bd0a-4e62-b994-6d0768ea647a2023-12-29WarningsExact identifier
application number: M012
Tussin CF Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketc19b9997-4037-48f3-b905-86da421a292d2023-12-29WarningsExact identifier
application number: M012
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.0239ada0-644d-4ef4-a3b8-df70246a3bc22023-12-21WarningsExact identifier
application number: M012
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.a698502d-c1c5-41ca-8142-74338b834c8b2023-12-21WarningsExact identifier
application number: M012
Father Johns Cough Medicine PlusNASAL DECONGESTANTOakhurst Company8b8aab0f-251b-6bd8-e053-2995a90ad7482023-12-18WarningsExact identifier
application number: M012
Father Johns MedicineDEXTROMETHORPHAN HBROakhurst Company8b8a249d-55af-cc98-e053-2995a90a431d2023-12-18WarningsExact identifier
application number: M012
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATEDLil' Drug Store Products, Inc.e79d92d2-d73c-d44f-e053-2995a90a03d92023-12-15WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCL TABLETLil' Drug Store Products, Inc.e5339c39-1d66-b283-e053-2995a90a43172023-12-15WarningsExact identifier
application number: M012
Father Johns MedicineDEXTROMETHORPHAN HBRHumco Holding Group, Inca7b0669f-8da1-5a44-e053-2995a90a84d92023-12-15WarningsExact identifier
application number: M012
Ephedrine HydrochlorideEPHEDRINE HYDROCHLORIDEWalgreen Companybcb81dc1-d854-30c0-e053-2a95a90a9fc72023-12-14WarningsExact identifier
application number: M012
Allergy, Circle KDIPHENHYDRAMINE HCL 25MG TABLETLil' Drug Store Products, Inc.d1f370ac-e7f4-baf7-e053-2995a90a1e502023-12-14WarningsExact identifier
application number: M012
Circle K Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.a6a1e3d9-575c-4adf-beb6-c9719de55c672023-12-14WarningsExact identifier
application number: M012
Non-Drowsy Sinus Severe, Circle KACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store products, Inc.e78c456f-f62e-596d-e053-2995a90a23972023-12-14WarningsExact identifier
application number: M012
Non-Drowsy Max ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATEDLil' Drug Store Products, Inc.e79f1a92-d8ea-e3f9-e053-2a95a90a2d372023-12-14WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsbcc1a001-4176-485d-aaf0-2037ca65c6b82023-12-14WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsedb49b17-06a7-4c25-bc7c-d62c1deac7f12023-12-13WarningsExact identifier
application number: M012
Family Wellness Oxymetazoline No DripOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)0c006b1c-8ab2-4b9c-8738-e7001c1bb47d2023-12-11WarningsExact 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