FDA.reportPublic FDA data

Tussin Multi Symptom Cold CF

Product NDC
0904-6537
11-digit product format
009046537
Labeler code
0904
Product ID
0904-6537_7bcf4ed4-fdc2-4408-bc9b-ebbdae3aee70
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine
Dosage form
LIQUID
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20; 200; 10 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-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-1 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
Tussin Multi Symptom Cold CF
Brand name suffix
Adult
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL
GUAIFENESIN200 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/10mL

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
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1044949Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9958b7d-7060-422b-a098-c1925c246081Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6537-20Tussin Multi Symptom Cold CFAdult118 mL in 1 BOTTLE, PLASTICLIQUID1189
0904-6537-20Tussin Multi Symptom Cold CFAdult1 in 1 BOXLIQUID19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6537-20ML - Milliliter0904-6537be84ba7f-5f37-4d97-ad3f-2c45c64a5d5312016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6537TUSSIN MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20241030_a9958b7d-7060-422b-a098-c1925c246081.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 158 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergenb173cc2c-7c4c-4f9e-a920-c71bc256ec1e2024-07-18WarningsExact identifier
application number: M012
ALLERGYCHLORPHENIRAMINE MALEATEA-S Medication Solutionsb199b5ee-fff3-4746-be68-a04060586f8e2024-07-18WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLH E B2d1715b3-b1cf-455d-9909-f6d58c97db402024-07-18WarningsExact identifier
application number: M012
careone allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEAmerican Sales Companyed4038fc-ab39-4567-9961-2b390b91b1262024-07-17WarningsExact identifier
application number: M012
Topcare childrens allergyDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC6b784cde-3152-4421-a825-dd1fc601aa7a2024-07-17WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreens4c6b6379-3a7f-4507-a792-7b69a7f3ba822024-07-17WarningsExact identifier
application number: M012
Mucus Relief Cold Flu Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens04defcf6-e20e-402b-b725-d9394a0146b12024-07-16WarningsExact identifier
application number: M012
basic care allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC7d237d37-21c7-476d-a8b7-d91ea1b472ee2024-07-16WarningsExact identifier
application number: M012
Berkley and Jensen Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEBJWCb52fc311-8853-4116-941b-8be35456abba2024-07-16WarningsExact identifier
application number: M012
Mucus Relief All In One Daytime Nighttime Cold Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCLWalgreens0b9a4438-7d13-484c-a614-2dedc24974dc2024-07-16WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HYDROCHLORIDEPublix Super Markets Inc23a98385-28cc-4fac-8c87-b3ced81065322024-07-16WarningsExact identifier
application number: M012
Walgreens Moisturizing Ultra Fine Mist with Aloe0.05% OXYMETAZOLINEWalgreens Companyaad01028-cbe0-4c10-adbc-d157bfa5af092024-07-16WarningsExact identifier
application number: M012
Basic Care severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC924bf427-b054-46af-b341-ff162946cd582024-07-15WarningsExact identifier
application number: M012
Maximum Strength Cold TabsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEJHK DBA American Safety & First Aide7d4fe9a-eb09-4266-90c9-290f61ce6ad02024-07-15WarningsExact identifier
application number: M012
ACTIDOM DACHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLC7797c22e-ffeb-4798-9fb6-aa64cf077ba72024-07-15WarningsExact identifier
application number: M012
Nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION1cf3064d-4ddd-63b9-e063-6294a90aa5472024-07-11WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLTARGET CORPORATION1ccbdb53-3f70-28da-e063-6394a90a9ae02024-07-09WarningsExact identifier
application number: M012
AXIV Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1cd2a6f1-31ad-e507-e063-6394a90aba582024-07-09WarningsExact identifier
application number: M012
Poly Hist ForteDOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.8aa0015b-8fc1-7951-e053-2a95a90a8e722024-07-09WarningsExact identifier
application number: M012
DECONEX DMXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.8aab8e5c-1633-2e5a-e053-2a95a90adcc52024-07-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044949dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSNa9958b7d-7060-422b-a098-c1925c2460819
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDa9958b7d-7060-422b-a098-c1925c2460819
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYa9958b7d-7060-422b-a098-c1925c2460819
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSYa9958b7d-7060-422b-a098-c1925c2460819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6537-20009046537201 BOTTLE, PLASTIC in 1 BOX (0904-6537-20) / 118 mL in 1 BOTTLE, PLASTIC2015-11-300000-00-00NoNoCurrent