FDA.reportPublic FDA data

Childrens Cough

Product NDC
49035-773
11-digit product format
490350773
Labeler code
49035
Product ID
49035-773_9cbd6363-5acb-4d86-ad1f-d99dca1655d2
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Wal-Mart Stores, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5; 100 mg/5mL; mg/5mL
Pharmacologic classes
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]
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
Childrens Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
50a0eaa5-fa73-4d84-86fc-3546c85cf353Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-773-03Childrens Cough118 mL in 1 BOTTLELIQUID1184
49035-773-03Childrens Cough1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-773CHILDRENS COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WAL-MART STORES, INC.]4Current NDC, Legacy NDC, 2 package rows20241222_50a0eaa5-fa73-4d84-86fc-3546c85cf353.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 106 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique ChlorphenCHLORPHENIRAMINE MALEATEUnifirst First Aid Corporationb3d5d161-8d4c-f1bb-e053-2a95a90a5bc52025-09-08WarningsExact identifier
application number: M012
Crane Safety Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDECrane Safety LLC968baa85-ce0e-0c3d-e053-2995a90ac03a2025-09-08WarningsExact identifier
application number: M012
Thompson Cherry Cough DropsMENTHOLThompson Safety LLCc948f5b0-8491-6f9f-e053-2995a90a55fa2025-09-08WarningsExact identifier
application number: M012
Medique Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione64c283b-0efa-0bfd-e053-2a95a90ab71d2025-09-08WarningsExact identifier
application number: M012
Daytime Nighttime Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATEWalgreensa99fdd49-0160-4a82-983b-fa56ab38ae762025-09-08WarningsExact identifier
application number: M012
Dye Free Wal Dryl Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEWalgreens53e6f72d-15a4-4efe-8b1f-5753fed53df82025-09-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreens40bfd631-51a4-4684-9ba0-a365d61da9bc2025-09-08WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensf796ce1f-3077-4a0d-a41a-249c345ddb5f2025-09-08WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc6ccbd537-2264-4b3c-804e-3d3ea5368a5f2025-09-05WarningsExact identifier
application number: M012
Ephedrine SulfateEPHEDRINE SULFATEWalgreen Companydc0072f9-7111-1af0-e053-2a95a90aed562025-09-04WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBrACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS Pharmacy, Inc31aa77e0-cfdb-57a8-e063-6394a90af98c2025-09-04WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATECVS Pharmacy, Inc.4bb70a55-de44-3dc1-e054-00144ff8d46c2025-09-04WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATECVS PHARMACYa645b31e-7da7-4fe6-a04f-ac794ef524942025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de637b1-3402-db86-e063-6294a90ac9812025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CMedical Group Care LLCf4a9cfec-0725-8f4a-e053-2995a90a1b4a2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de65c99-6c2d-3650-e063-6394a90aa98c2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREEMedical Group Care LLCf4a9d879-4736-4f63-e053-2995a90adeba2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de66240-441c-00ad-e063-6294a90a4a052025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CMedical Group Care LLCff99c57a-e06a-69d3-e053-6394a90a67752025-09-03WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de7ace0-e389-b751-e063-6394a90ab4e92025-09-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN50a0eaa5-fa73-4d84-86fc-3546c85cf3534
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD50a0eaa5-fa73-4d84-86fc-3546c85cf3534
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY50a0eaa5-fa73-4d84-86fc-3546c85cf3534
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY50a0eaa5-fa73-4d84-86fc-3546c85cf3534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-773-03490350773031 BOTTLE in 1 CARTON (49035-773-03) / 118 mL in 1 BOTTLE1 bottle2017-08-010000-00-00NoNoCurrent