FDA.reportPublic FDA data

equate childrens cold cough

Product NDC
79903-349
11-digit product format
799030349
Labeler code
79903
Product ID
79903-349_6cffca21-e002-4dd6-bd56-4477ee845342
Type
HUMAN OTC DRUG
Nonproprietary name
brompheniramine maleate, dextromethorphan hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
WALMART INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-05
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2; 10 mg/10mL; mg/10mL
Pharmacologic classes
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
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
equate childrens cold cough
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IXA7C9ZN03Internal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2683421Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
24758ab0-ba08-4b4a-9861-449612bdb89cAvailable 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-349-04equate childrens cold cough118 mL in 1 BOTTLESOLUTION1182
79903-349-04equate childrens cold cough1 in 1 CARTONSOLUTION12

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 156 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Exchange Select NasalOXYMETAZOLINE HCLArmy & Air Force Exchange Service40d2090d-c332-4dcb-9f43-5ee467e7b3d12024-08-27WarningsExact identifier
application number: M012
Signature Care Nasal DecongestantOXYMETAZOLINE HCLSafeway23f0a5b3-59ae-4eb3-9b7d-e6a4920603372024-08-27WarningsExact identifier
application number: M012
DG Health NasalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCdebcda99-c605-4941-b873-9e4dbae274832024-08-27WarningsExact identifier
application number: M012
Good Neighbor Pharmacy NasalOXYMETAZOLINE HCLAmerisource Bergend374d697-2b57-4558-a20b-d3d89aea82d72024-08-27WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HCLMeijer Distribution Inc3984cbc3-b60c-40a7-bc3a-7d1f600503ac2024-08-27WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDEStrategic Sourcing Services LLCe6e51821-03ae-4ec3-82a9-b4a8feacd9962024-08-27WarningsExact identifier
application number: M012
Pyrilamine Maleate and Dextromethorphan HydrobromidePYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWestminster Pharmaceuticals, LLCdd068449-9d24-41e6-8a6e-f69c9fe263f22024-08-26WarningsExact identifier
application number: M012
basic care nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCa154e500-2b45-4242-a26c-9530849f99df2024-08-23WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0c0cf76f-2dd3-45ef-e063-6394a90a9fef2024-08-22WarningsExact identifier
application number: M012
Day Cold and Flu and Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLTARGET CORPORATION08ee56d1-b11d-3e36-e063-6294a90acd5f2024-08-22WarningsExact identifier
application number: M012
Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDETARGET CORPORATION0fc523ce-55a7-6384-e063-6394a90aad3f2024-08-22WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreens8045aef9-22bc-4146-b494-dbb1ffef06df2024-08-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.5a2053d4-9c0d-4613-9cf5-0067173f37302024-08-16WarningsExact identifier
application number: M012
QUALITY CHOICE Long Acting Cough SoftgelDEXTROMETHORPHAN HYDROBROMIDEChain Drug Marketing Association, Inc.f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c2024-08-16WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLPadagis Israel Pharmaceuticals Ltd458594e1-8d99-4de3-8923-2fd8ce2fc4062024-08-16WarningsExact identifier
application number: M012
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC54e0d57e-1f48-45e2-86b3-0e50775996f42024-08-15WarningsExact identifier
application number: M012
SanaTos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC1fc1408c-c540-39ab-e063-6394a90aa4772024-08-15WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.489645ad-d7da-5f52-e054-00144ff8d46c2024-08-14WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation6c949602-e0c8-40ce-8fb3-5147f406fa042024-08-14WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.3dbdf020-ca17-1197-e054-00144ff8d46c2024-08-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral SolutionPSN24758ab0-ba08-4b4a-9861-449612bdb89c2
2683421brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD24758ab0-ba08-4b4a-9861-449612bdb89c2
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral SolutionSY24758ab0-ba08-4b4a-9861-449612bdb89c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-349-04799030349041 BOTTLE in 1 CARTON (79903-349-04) / 118 mL in 1 BOTTLE1 bottle2025-05-05NoNoCurrent