FDA.reportPublic FDA data

ACTINEL

Product NDC
63102-101
11-digit product format
631020101
Labeler code
63102
Product ID
63102-101_11f69bba-6b7f-4876-a8ba-123264408164
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
ACTIPHARMA, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-24
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
15; 200; 30 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
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
ACTINEL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL
GUAIFENESIN200 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1098227Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db0cb6ae-0a4d-4232-805a-f3f3a058261fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63102-101-162023-10-18C16284748780-10191ceaa-706a-198a-e063-dbdaa90aec3eACTINEL ®
63102-101-162023-07-28C16284748780-10191ceaa-706a-198a-e063-dbdaa90aec3eACTINEL ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-101-16ACTINEL474 mL in 1 BOTTLESOLUTION4746

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63102-101-16ML - Milliliter63102-101f2212955-c84c-44f7-9dc8-cc54a6f7145b12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
GUAIFENESINACTIVE MOIETY495W7451VQACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63102-101ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, LLC]5Current NDC, Legacy NDC, 1 package rows20240814_db0cb6ae-0a4d-4232-805a-f3f3a058261f.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 96 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quantum Health Bing Cherry FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.94d40c95-fa2b-42cf-b9f5-a5027d86401d2025-10-20WarningsExact identifier
application number: M012
Quantum Health Meyer Lemon and Honey FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.fe780067-5a20-4d55-a108-91237cd9e5f42025-10-20WarningsExact identifier
application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)DIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.4157e680-37ac-eb4c-e063-6394a90a2a992025-10-17WarningsExact identifier
application number: M012
Norel ADACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCLU.S. PHARMACEUTICAL CORPORATION53d9ed3c-212d-4b12-ac35-8bd49382b49d2025-10-17WarningsExact identifier
application number: M012
Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED92c570ff-139f-49ff-a7bd-8a540ecc07c72025-10-17WarningsExact identifier
application number: M012
NoHist DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.6aafe912-28ff-442f-8e07-b3c5993ac9432025-10-16WarningsExact identifier
application number: M012
Signature Care OriginalOXYMETAZOLINE HYDROCHLORIDESAFEWAY, INC.f7ad687b-dcaf-928c-e053-6294a90a6abe2025-10-16WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)90ccb29c-9967-46cb-a409-e440344e1a1a2025-10-15WarningsExact identifier
application number: M012
Robitussin Childrens Honey Day Night DM Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCf9999875-3433-4052-a628-39539d3732162025-10-15WarningsExact identifier
application number: M012
Robitussin Day and Night Cough Relief Value PackDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATEHaleon US Holdings LLC4029eccd-5443-4ae2-9232-2a1d922798f82025-10-15WarningsExact identifier
application number: M012
EndaCof DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.c68ea55a-8b9a-4a70-8b5c-1a27366518132025-10-15WarningsExact identifier
application number: M012
DURATUSS DMDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.413a3951-d704-f14b-e063-6394a90a06dc2025-10-15WarningsExact identifier
application number: M012
LoHist DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.29730dab-fa09-4351-9b36-0359ba4f77442025-10-15WarningsExact identifier
application number: M012
M-END DMXDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDER. A. McNeil Companyee1fae2e-3a21-4487-9989-c7620a4a70562025-10-15WarningsExact identifier
application number: M012
Chlo TussCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDER.A. McNeil Company43610aaa-8b94-40d5-ae09-3d75bd2317c82025-10-15WarningsExact identifier
application number: M012
Chlo HistCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATER. A. McNeil Companyd046f4ba-5753-4ed5-a924-0b66fd1167812025-10-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)6ca7372b-50c4-4b15-b133-fefa35525ade2025-10-15WarningsExact identifier
application number: M012
Extra Strength Sinus Relief Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH0d8a009c-30b5-4f12-90bd-f8aa1110243f2025-10-14WarningsExact identifier
application number: M012
Tussin DM Cough plus Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCardinal Health 110, Inc. DBA LEADER9d11f443-c93d-44e8-b5a3-2677b7b112122025-10-14WarningsExact identifier
application number: M012
Rompe Pecho SFGUAIFENESINEfficient Laboratories, Inc.31ff48fc-9603-413c-ab7c-2598b3e08f9c2025-10-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098227dextromethorphan HBr 15 MG / guaiFENesin 200 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSNdb0cb6ae-0a4d-4232-805a-f3f3a058261f6
1098227dextromethorphan hydrobromide 3 MG/ML / guaifenesin 40 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCDdb0cb6ae-0a4d-4232-805a-f3f3a058261f6
1098227dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSYdb0cb6ae-0a4d-4232-805a-f3f3a058261f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63102-101-1663102010116474 mL in 1 BOTTLE (63102-101-16) 474 ml2014-09-240000-00-00NoNoCurrent