CVS Childrens Cough Relief

Product NDC
69842-577
11-digit product format
698420577
Labeler code
69842
Product ID
69842-577_4ce33b05-0044-4e78-9d09-bfe66c3b79e5
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-14
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
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
CVS Childrens Cough Relief
Listing expiration
2027-12-31

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
fe12f3bd-3237-42d1-aec5-c831b9637175Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-577-04CVS Childrens Cough Relief118 mL in 1 BOTTLELIQUID1185
69842-577-04CVS Childrens Cough Relief1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-577CVS CHILDRENS COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [CVS PHARMACY, INC]4Current NDC, Legacy NDC, 2 package rows20240823_fe12f3bd-3237-42d1-aec5-c831b9637175.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 8 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Overnight Cold and Flu Clear and CoolACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDECVS PHARMACY, INC2497a011-d7a0-4d69-97e2-bbf25a99b1cc2026-08-17WarningsExact identifier
application number: M012
Mucus Relief Cough Cold Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E B3ef949f5-ac8c-44be-b04d-6996fa59a94b2026-08-17WarningsExact identifier
application number: M012
Sinus PE Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLC28a4ec37-11dd-4134-81aa-851f081bf0882026-08-17WarningsExact identifier
application number: M012
CVS Health No DripNASAL MISTCVS PHARMACY,INC.60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa2026-08-17WarningsExact identifier
application number: M012
Daytime Cold and Cough and NightTime Cold and Congestion ChildrensBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreens2bdc62b6-f3e1-4a79-9b29-00cc1d4280b32026-08-17WarningsExact identifier
application number: M012
CVS Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS HEALTHf01ab8ef-d29a-4e33-8a14-4c57ccdcc0d62026-08-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.23750ea1-18a4-bfa7-e063-6394a90afd092026-08-16WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLKROGER COMPANY30d50bbe-0a14-c985-e063-6294a90a47b32026-08-16WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE77f87e19-a9d5-479d-9434-bbde13210bfb2026-08-15WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. DBA Leaderb1c2055b-4b5a-4fa2-b600-8930c9c8524c2026-08-15WarningsExact identifier
application number: M012
Nighttime HBP Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY146c9a62-0418-4b5d-9074-5be8a05f3f932026-08-15WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
application number: M012
Nasal Decongestant Maximum Strength, Non-DrowsyPSEUDOEPHEDRINE HCLAmerisource Bergen1fdb1ba5-4072-4baf-9e30-f01d57bf6d822026-08-15WarningsExact identifier
application number: M012
Cold and Flu NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Company32c67914-d7cf-40ee-8682-0ba8ed6912872026-08-15WarningsExact identifier
application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
application number: M012
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
application number: M012
NasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCe7c8ffed-83b8-4088-b72c-d937e93f8b542026-08-14WarningsExact identifier
application number: M012
CVS Mucus Relief DM and Overnight Cold and FluDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCLCVS75520b77-d40b-4f43-b92a-7a3eba5b493f2026-08-14WarningsExact identifier
application number: M012
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact 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 SolutionPSNfe12f3bd-3237-42d1-aec5-c831b96371755
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDfe12f3bd-3237-42d1-aec5-c831b96371755
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYfe12f3bd-3237-42d1-aec5-c831b96371755
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYfe12f3bd-3237-42d1-aec5-c831b96371755

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-577-04698420577041 BOTTLE in 1 CARTON (69842-577-04) / 118 mL in 1 BOTTLE1 bottle2022-03-140000-00-00NoNoCurrent