FDA.reportPublic FDA data

CHILDRENS COLD AND COUGH

Product NDC
59640-200
11-digit product format
596400200
Labeler code
59640
Product ID
59640-200_776bde57-0ff7-4931-a6f3-159083fc93d5
Type
HUMAN OTC DRUG
Nonproprietary name
brompheniramine maleate, dextromethorphan hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-04
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
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 COLD AND COUGH
Listing expiration
2026-12-31

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
08f4785a-c628-4e9b-9412-b2a817f9be60Available 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
59640-200-26CHILDRENS COLD AND COUGH118 mL in 1 BOTTLESOLUTION1182
59640-200-26CHILDRENS COLD AND 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 10 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d22026-08-10WarningsExact identifier
application number: M012
TRIPROLIDINE HYDROCHLORIDETRIPROLIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa9f01760-e335-4410-a9b8-8edce28412702026-08-10WarningsExact identifier
application number: M012
GuaifedGUAIFENESINAldama Pharmaceuticals, Inc38f37272-2084-a33b-e063-6294a90ac1502026-08-10WarningsExact identifier
application number: M012
Chlorpheniramine MaleateCHLORPHENIRAMINE MALEATEPD-Rx Pharmaceuticals, Inc.7a3452a2-930f-48b1-8c59-dbceb10b9c782026-08-10WarningsExact identifier
application number: M012
Guaifed DMDEXTROMETHORPHAN, GUAIFENESINAldama Pharmaceuticals, Inc396bf716-0f61-9563-e063-6394a90a171b2026-08-10WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpeff114fe-fb15-48dd-b673-4d4d66406e692026-08-10WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)651b03a3-b85e-4028-a9f2-472bec16c8f42026-08-10WarningsExact identifier
application number: M012
NASALPHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC02a89765-2a75-470a-9fd6-8cce71dc19e92026-08-10WarningsExact identifier
application number: M012
WINCO Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWINCO FOODS, LLCf34bfb71-2c81-44d0-a2a0-4d320c43c2172026-08-07WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME ELDERBERRY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company11cac20e-9bb6-4e2d-8efd-4451f055c7b42026-08-07WarningsExact identifier
application number: M012
Winco Foods Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWINCO FOODS, LLC1d02b32a-e88d-4c70-b66d-7bdc22c25a432026-08-07WarningsExact identifier
application number: M012
foster and thrive daytime cold and flu relief nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCc1ecc56b-8052-4b0a-900a-dc93a24771bd2026-08-07WarningsExact identifier
application number: M012
Adult Long Lasting Cough ReliefDEXTROMETHORPHAN HBRShield Pharmaceuticals Corpbbf7d296-fa3d-43e5-984c-e9d2881a074d2026-08-07WarningsExact identifier
application number: M012
Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEWinCo Foods, LLC790d534a-0f40-495b-a815-67851ac3d20d2026-08-07WarningsExact identifier
application number: M012
Extra Moisturizing Nasal Pump Mist Anti DripOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLC46ebd262-c6a4-43ea-a7f6-506561bb3de42026-08-07WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINWINCO FOODS, LLCe6afa830-6ce2-4abc-b5c9-3f5f156444df2026-08-07WarningsExact identifier
application number: M012
Sinus PE Pressure plus Pain MAXIMUM STRENGTHACETAMINOPHEN, PHENYLEPHRINE HCLCVS Pharmacya3b073b4-494c-4531-b08e-475c86ba321d2026-08-07WarningsExact identifier
application number: M012
Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEWinCo Foods, LLCdc56197c-c108-4b35-b791-dde5c3384ddd2026-08-07WarningsExact identifier
application number: M012
Sinus Severe Non Drowsy, DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.84c30ec9-a7b5-4d2f-95b2-d6fb895945de2026-08-07WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC887cabe5-46d0-4f4e-8f5a-2cfdbc157b582026-08-07WarningsExact 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 SolutionPSN08f4785a-c628-4e9b-9412-b2a817f9be602
2683421brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD08f4785a-c628-4e9b-9412-b2a817f9be602
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral SolutionSY08f4785a-c628-4e9b-9412-b2a817f9be602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59640-200-26596400200261 BOTTLE in 1 CARTON (59640-200-26) / 118 mL in 1 BOTTLE1 bottle2025-11-04NoNoCurrent