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 85 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores,Inc.,770c0e4f-0eed-4b8c-85a5-761b6a84db622025-12-02WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWAL-MART STORES INCa2a7e568-bff8-4818-a31d-7c2efa1859c32025-12-02WarningsExact identifier
application number: M012
DayTime Severe, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLETLil' Drug Store Products, Inc.44fa0193-2a19-bdc1-e063-6394a90a60e82025-12-02WarningsExact identifier
application number: M012
Nighttime Severe, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.44fb9958-d771-f4b3-e063-6294a90a91352025-12-02WarningsExact identifier
application number: M012
Quality Choice Mucus ReliefGUAIFENESINChain Drug Marketing Associationf1a73da7-0dbb-49bd-857e-7dd6bc11b63c2025-12-02WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 70000ac74be47-30f0-418b-bd07-502feaa9723f2025-12-01WarningsExact identifier
application number: M012
Walgreens High Blood Pressure Cold and FluACETAMINOPHEN, DEXTROMETHORPHANWALGREENS CO.bc83b55e-c3d8-460f-8ef9-ff7b2e4f72722025-12-01WarningsExact identifier
application number: M012
Walgreen High Blood Pressure Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREENS CO.f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a2025-12-01WarningsExact identifier
application number: M012
Walgreens Nighttime Kids Honey Cold Cough CongestionDOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS COc0f317cd-723d-47f2-b600-aaeae63994822025-12-01WarningsExact identifier
application number: M012
Walgreen Maximum Strength Severe Congestion and coughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALGREENS CO.b4abcb6d-f3e1-4d63-98cf-ff556ec423b62025-12-01WarningsExact identifier
application number: M012
Walgreens Daytime ChildrensCOUGH AND CHEST CONGESTIONWALGREENS CO.dd99675f-3860-42ef-999c-d9a3746a38c02025-12-01WarningsExact identifier
application number: M012
Adult Cough plus Chest Congestion DM with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINWALGREEN COMPANY5f5af13a-c2a3-4bbe-880e-9c57b36e92342025-12-01WarningsExact identifier
application number: M012
Walgreens Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWALGREEN COMPANYb2e08f4d-9753-4767-a8eb-3740dd1034cc2025-12-01WarningsExact identifier
application number: M012
WALGREENS Cold Cough and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.1e903034-942e-4c6e-9f96-eb097c2665802025-12-01WarningsExact identifier
application number: M012
Walgreens DAY and NIGHT PACKDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATEWALGREEN COcb87e57b-ff06-4973-9751-137c7021e2722025-12-01WarningsExact identifier
application number: M012
WALGREEN Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWALGREENS CO.b7b1d604-921d-4ae7-93de-dcf690d421b42025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLMeijer Distribution Inc235b2866-bbda-7148-e063-6394a90a898f2025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWhole Foods Market, INC.32352109-31dc-8e6f-e063-6294a90a2f922025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.323347c3-d51a-4976-e063-6294a90a952e2025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWALGREEN COMPANY2969ba8f-c477-222a-e063-6394a90af7032025-12-01WarningsExact 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