FDA.reportPublic FDA data

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 104 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLD AND FLU DAYTIME-NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9fab3-890a-158d-e053-2a95a90af4232025-09-13WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPrecision Dose, Inc.4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea42025-09-12WarningsExact identifier
application number: M012
Nasal Spray, Circle KOXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTIONLil' Drug Store Products, Inc.3ea06e88-a2c6-621b-e063-6294a90a10752025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHarris Teeter, LLCa0090dc6-0fe5-4ab2-a2cf-6ed19892f3632025-09-12WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCICVS Pharmacyebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e2025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)8d7bb31b-a47d-4252-a0a7-79d286179fb92025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)150e5c3a-7c86-4b66-af30-a376df6974012025-09-12WarningsExact identifier
application number: M012
SEVERE COUGH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED67f8d405-a2ad-4ade-93b4-9b09a0d81d8e2025-09-11WarningsExact identifier
application number: M012
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.3862aaa5-2281-e8f9-e063-6294a90a0f7e2025-09-09WarningsExact identifier
application number: M012
McKesson Sugar Free Cough Suppressant Oral AnestheticMENTHOL LOZENGEMcKesson Medical-Surgicale0dfa6ca-b311-25cb-e053-2a95a90a12cc2025-09-09WarningsExact identifier
application number: M012
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione648f017-9e30-df6c-e053-2995a90adcd02025-09-09WarningsExact identifier
application number: M012
Medi-First Honey Lemon Cough DropsMENTHOL 8.6 MGUnifirst First Aid Corporation826e1b87-e5a9-8637-e053-2991aa0aded12025-09-09WarningsExact identifier
application number: M012
Unishield Cherry CoughMENTHOLUnishieldb8297bc1-44b2-3de0-e053-2995a90ad01b2025-09-09WarningsExact identifier
application number: M012
McKesson Cough SupressantMENTHOLMcKesson Medical-Surgicaldb5e0490-2ed8-2d53-e053-2a95a90a98f52025-09-09WarningsExact identifier
application number: M012
Duratuss ACCODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.3e5ed178-d5d9-b8d4-e063-6394a90a91db2025-09-09WarningsExact identifier
application number: M012
Rompe Pecho CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLEfficient Laboratories Inc96c4dee1-6e66-4442-a7e3-56e874414c172025-09-09WarningsExact identifier
application number: M012
Nighttime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc57c458ed-7987-453b-ab24-bbfa6580f9202025-09-09WarningsExact identifier
application number: M012
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.38637189-d1ee-9405-e063-6394a90ae8b82025-09-09WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreensfd52d8d8-7cd1-4e92-86da-354a1d5213c22025-09-08WarningsExact identifier
application number: M012
Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione8e5fb21-a7fd-44d1-b9c4-83e949699ca62025-09-08WarningsExact 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