FDA.reportPublic FDA data

Childrens Cough and Congestion, Childrens Cold and Cough

Product NDC
79903-414
11-digit product format
799030414
Labeler code
79903
Product ID
79903-414_b60995e4-c08b-45a5-807e-d0ebe04bc702
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Doxylamine succinate, Guaifenesin
Dosage form
KIT
Labeler
WALMART INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-19
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
Childrens Cough and Congestion, Childrens Cold and Cough
Brand name suffix
Day, Night
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1298228Internal RxNorm lookup
2743624Internal RxNorm lookup
2743625Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
312ae879-1124-40a4-b2ba-3f3070840021Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
79903-412-08Childrens Cough and Congestion, Childrens Cold and CoughDay, Night237 mL in 1 BOTTLE, PLASTICSOLUTION237 mL100 mg in 15mL1
79903-413-08Childrens Cough and Congestion, Childrens Cold and CoughDay, Night237 mL in 1 BOTTLE, PLASTICSOLUTION237 mL6.25 mg in 15mL1
79903-414-16Childrens Cough and Congestion, Childrens Cold and CoughDay, Night1 in 1 PACKAGEKIT11
79903-414-16Childrens Cough and Congestion, Childrens Cold and CoughDay, Night1 in 1 KITKIT11

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 136 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICE Honey Lemon Cough DropsMENTHOLLeosons Overseas Corp96da2c9d-2d0d-6252-e053-2995a90ac3382024-11-19WarningsExact identifier
application number: M012
SanaTos BoostDEXTROMETHORPHAN HBRPharmadel LLCae6a424f-f3f0-3f6c-e053-2995a90a972d2024-11-18WarningsExact identifier
application number: M012
SanaTos Turbo Max StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLCd56a071c-a747-5397-e053-2995a90aad8b2024-11-18WarningsExact identifier
application number: M012
equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa24021a0-ef68-4bce-ba53-d262d1025cc02024-11-17WarningsExact identifier
application number: M012
Cold and Cough DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Inc4d5f93c1-7752-4948-ba58-c4385cfc24c82024-11-17WarningsExact identifier
application number: M012
Good Sense Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company8a87104f-94a4-4585-afd5-d610eea32e392024-11-17WarningsExact identifier
application number: M012
equate childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Incc91e94f4-4c51-4fe7-ad2e-0b9dc58b51e42024-11-17WarningsExact identifier
application number: M012
foster and thrive childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services LLC1eac715b-351c-4b47-8d1d-6e921813c1a42024-11-15WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC298d2796-5ae5-4346-b6d2-2ced2dd29dc32024-11-15WarningsExact identifier
application number: M012
dg health day time severe cold and flu relief night time severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEDolgencorp, LLCf721b393-9ad5-4fc6-a2c5-bd89e58caf162024-11-15WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f22024-11-15WarningsExact identifier
application number: M012
Rompe Pecho EXGUAIFENESINEfficient Laboratories Inc89ea23a5-0da7-407e-83d9-77a0b562f3af2024-11-14WarningsExact identifier
application number: M012
basic care daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLCceb342da-ff6d-4c19-9f78-0033d028075e2024-11-14WarningsExact identifier
application number: M012
Topcare Nite Time Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCefb8e0e2-0795-4f4a-8ca6-955f33bee1432024-11-14WarningsExact identifier
application number: M012
good neighbor pharmacy nasal fourPHENYLEPHRINE HYDROCHLORIDEAmerisource Bergena3d637dc-d957-458c-8a75-f948601a31aa2024-11-14WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Incec8db98f-4fd1-4644-b76f-ff04f72e87f42024-11-13WarningsExact identifier
application number: M012
dg health tussinDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, LLC6f9b8267-1e0b-430b-8e44-06408ae82ea42024-11-13WarningsExact identifier
application number: M012
Walgreens Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalgreensb60e2cf9-11ec-469e-e053-2a95a90a712a2024-11-13WarningsExact identifier
application number: M012
Kroger Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEKroger Company69333774-3cf4-384d-e053-2a91aa0a48b32024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEH. E. Butt Grocery Company6403fe3d-d82b-f4d5-e053-2991aa0ac7d62024-11-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2743625{1 (dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral Solution) } PackGPCK312ae879-1124-40a4-b2ba-3f30708400211
27436251 daytime (dextromethorphan hydrobromide 10 MG / guaiFENesin 100 MG in 15 mL) / 1 nighttime (dextromethorphan hydrobromide 10 MG/ML / doxylamine succinate 6.25 MG in 15 mL) PackPSN312ae879-1124-40a4-b2ba-3f30708400211
2743624dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 mL Oral SolutionPSN312ae879-1124-40a4-b2ba-3f30708400211
1298228dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral SolutionPSN312ae879-1124-40a4-b2ba-3f30708400211
2743624dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD312ae879-1124-40a4-b2ba-3f30708400211
1298228dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral SolutionSCD312ae879-1124-40a4-b2ba-3f30708400211
27436251 daytime (dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 mL) / 1 nighttime (dextromethorphan hydrobromide 10 MG/ML / doxylamine succinate 6.25 MG per 15 mL) PackSY312ae879-1124-40a4-b2ba-3f30708400211
2743624dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral SolutionSY312ae879-1124-40a4-b2ba-3f30708400211
1298228dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral SolutionSY312ae879-1124-40a4-b2ba-3f30708400211
1298228dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 ML Oral SolutionSY312ae879-1124-40a4-b2ba-3f30708400211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-412-0879903041208237 mL in 1 BOTTLE, PLASTIC237 mlHistorical
79903-413-0879903041308237 mL in 1 BOTTLE, PLASTIC237 mlHistorical
79903-414-16799030414161 KIT in 1 PACKAGE (79903-414-16) / 1 KIT in 1 KIT * 237 mL in 1 BOTTLE, PLASTIC (79903-412-08) * 237 mL in 1 BOTTLE, PLASTIC (79903-413-08) 1 kit2026-05-19NoNoCurrent