FDA.reportPublic FDA data

VICKS CHILDRENS

Product NDC
69423-997
11-digit product format
694230997
Labeler code
69423
Product ID
69423-997_4df61d65-70d2-069b-e063-6294a90a5073
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Diphenhydramine HCl, Guaifenesin, Phenylephrine Hydrochloride
Dosage form
KIT
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-09
Marketing end
2026-12-31
NDC exclude flag
No
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
VICKS CHILDRENS
Brand name suffix
COUGH CONGESTION

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2166123Internal RxNorm lookup
2166129Internal RxNorm lookup
2626496Internal RxNorm lookup
2626497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f1d67797-c806-261d-e053-2a95a90a3c15Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-712-06VICKS CHILDRENSCOUGH CONGESTION177 mL in 1 BOTTLE, PLASTICLIQUID177 mL5 mg in 15mL6
69423-982-06VICKS CHILDRENSCOUGH CONGESTION177 mL in 1 BOTTLE, PLASTICLIQUID177 mL5 mg in 15mL6
69423-997-12VICKS CHILDRENSCOUGH CONGESTION1 in 1 PACKAGEKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-997VICKS CHILDRENS COUGH CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]4Current NDC, Legacy NDC, 3 package rows20241012_f1d67797-c806-261d-e053-2a95a90a3c15.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 102 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MGC Health Cough Drops Honey HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa17272-fd7f-9ab4-e063-6394a90a585f2025-09-25WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa2e438-2ff3-a2df-e063-6394a90ac7b52025-09-25WarningsExact identifier
application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANTGUAIFENESINQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)63dad603-fe2f-42a6-a626-5c8048a42c102025-09-25WarningsExact identifier
application number: M012
Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa5220f-38bb-9ef6-e063-6294a90aeff82025-09-25WarningsExact identifier
application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHealth Pharma USA LLCa03befb4-d86d-43e4-8097-eda5c8bb25be2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f8d7d47-f14c-888c-e063-6394a90a5cdd2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3f909bc2-eb84-a19d-e063-6294a90ae04e2025-09-24WarningsExact identifier
application number: M012
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories, Inc3f79137f-f0b0-d22c-e063-6394a90a72452025-09-23WarningsExact identifier
application number: M012
GoodSense Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLGOOD SENSE240bb6af-9d38-49fe-9011-3016246b09862025-09-23WarningsExact identifier
application number: M012
Xpect Honey Lemon Cough DropsHONEY LEMON COUGH DROPSCintas Corporation79e0b7c1-4acc-41d2-89cd-d075a8bac0c92025-09-23WarningsExact identifier
application number: M012
Topcare NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCb2b3c450-e988-41d1-9e53-cc8e30d75cb42025-09-23WarningsExact identifier
application number: M012
Xpect Cherry Cough DropsCHERRY COUGH DROPSCintas Corporationd1fd2f23-5435-405d-a7fd-644691f79e802025-09-23WarningsExact identifier
application number: M012
Topcare DayTime NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC560fb22b-391f-4d7b-a6fd-38d577d404b02025-09-23WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f67ac3d-1503-3418-e063-6394a90a938f2025-09-22WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories Inc.3f68e68a-cf32-9df8-e063-6394a90a30122025-09-22WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKramer Novisf0bec5f5-4d76-471e-9024-557eba848b932025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.9f050fb0-6100-4b14-b82f-1d5fcbf165402025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.c6392ace-c7d1-4450-8b71-4dccc60b4f022025-09-22WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f12ee8f-d1c6-d73a-e063-6394a90a91992025-09-18WarningsExact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2025-09-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2626497{1 (dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.33 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } PackGPCKf1d67797-c806-261d-e053-2a95a90a3c156
26264971 daytime (dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL) PackPSNf1d67797-c806-261d-e053-2a95a90a3c156
2626496dextromethorphan HBr 0.667 MG/mL / guaiFENesin 13.33 MG/mL / phenylephrine HCl 0.333 MG/mL Oral SolutionPSNf1d67797-c806-261d-e053-2a95a90a3c156
2166123dextromethorphan Hbr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNf1d67797-c806-261d-e053-2a95a90a3c156
2166129diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNf1d67797-c806-261d-e053-2a95a90a3c156
2166123dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDf1d67797-c806-261d-e053-2a95a90a3c156
2626496dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.33 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDf1d67797-c806-261d-e053-2a95a90a3c156
2166129diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDf1d67797-c806-261d-e053-2a95a90a3c156
26264971 daytime (dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 15 mL) / 1 nighttime (diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 15 mL) PackSYf1d67797-c806-261d-e053-2a95a90a3c156
2166123dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 15 ML Oral SolutionSYf1d67797-c806-261d-e053-2a95a90a3c156
2166129diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 15 ML Oral SolutionSYf1d67797-c806-261d-e053-2a95a90a3c156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-712-0637000071206177 mL in 1 BOTTLE, PLASTIC177 mlHistorical
69423-982-0669423098206177 mL in 1 BOTTLE, PLASTIC177 mlHistorical
69423-997-12694230997121 KIT in 1 PACKAGE (69423-997-12) * 177 mL in 1 BOTTLE, PLASTIC (69423-982-06) * 177 mL in 1 BOTTLE, PLASTIC (37000-712-06) 1 kit2019-07-092026-12-31NoNoCurrent