FDA.reportPublic FDA data

Vicks childrens

Product NDC
69423-982
11-digit product format
694230982
Labeler code
69423
Product ID
69423-982_5afce721-d6c0-5bc6-e063-6294a90a03cd
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-22
Marketing end
2026-12-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Active strength
10; 5; 200 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL
GUAIFENESIN200 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal 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
2166123Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2356457-9791-3710-e053-2995a90ad140Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-982-06Vicks childrensCough Congestion177 mL in 1 BOTTLE, PLASTICLIQUID1777
69423-982-06VICKS CHILDRENSCOUGH CONGESTION177 mL in 1 BOTTLE, PLASTICLIQUID177 mL5 mg in 15mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-982VICKS CHILDRENS COUGH CONGESTION (PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, Legacy NDC, 1 package rows20241012_e2356457-9791-3710-e053-2995a90ad140.zip
69423-982VICKS CHILDRENS COUGH CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]4Current NDC, Legacy NDC20241012_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 155 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline nasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI07e0328e-1912-4f25-9e1e-9482d4665be02024-09-07WarningsExact identifier
application number: M012
Benadryl Allergy EXTRA STRENGTHDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCdd0a8069-18d8-5696-e053-2995a90a2f222024-09-06WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEPAI Holdings, LLC88d0994c-4270-4408-8837-bd97510b21182024-09-06WarningsExact identifier
application number: M012
QCH Maximum Strength Mucus Relief 617DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association Inc.a1c5c15e-0f3a-47d3-b9ed-1e00184175142024-09-06WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Nighttime Soft ChewsACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC6ba64bbe-7599-406a-9187-737c0f8c1c2a2024-09-05WarningsExact identifier
application number: M012
Cough Relief NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)344282fc-3bd1-4f49-9bd1-08c5a58d1f732024-09-05WarningsExact identifier
application number: M012
Equate NasalPHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc95ef1819-edc3-4dda-8514-85b61538cc722024-09-04WarningsExact identifier
application number: M012
Up and up nasalOXYMETAZOLINE HYDROCHLORIDETarget Corporation0c246c11-eadd-4ac6-bd58-5fdb151e06d62024-09-04WarningsExact identifier
application number: M012
Exchange Select NasalOXYMETAZOLINE HYDROCHLORIDEArmy & Air Force Exchange Serviceaafa9163-f08e-48c9-9ca1-7b72f67d007d2024-08-31WarningsExact identifier
application number: M012
nasal 12 hourOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Ince9ee03db-a070-4c2b-ac61-7fd22bab27952024-08-31WarningsExact identifier
application number: M012
dg health nasalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLC42b58928-e8e5-49e4-b49e-498d77d64fcd2024-08-28WarningsExact identifier
application number: M012
nasal mistOXYMETAZOLINE HCLCVS Pharmacyb71c557a-eb93-40d1-87c4-847f5468fc1e2024-08-28WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HCLKroger Company0a24d98a-5950-49de-8b77-ea880b08d2c52024-08-28WarningsExact identifier
application number: M012
basic care no drip nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLC96e018e2-e0b5-4802-a4a1-73a73d5740822024-08-28WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HCLTopco Associates LLCb5434599-5485-4949-9d76-b1ef3ad17c1a2024-08-28WarningsExact identifier
application number: M012
basic care no drip nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCb15eb271-7842-495b-aa0f-9b20def86dc12024-08-28WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCf1dd78e0-f700-4469-85d6-18cc299e87462024-08-28WarningsExact identifier
application number: M012
equaline nasalOXYMETAZOLINE HCLUnited Natural Foods, Inc. dba UNFI69308693-a094-42a9-a041-e73647a25cc12024-08-27WarningsExact identifier
application number: M012
signature care nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf9ac80d1-3753-412b-a407-18a6b50e5d1c2024-08-27WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.20ac6010-84f4-eeff-e063-6294a90a50a72024-08-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2166123dextromethorphan Hbr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNe2356457-9791-3710-e053-2995a90ad1407
2166123dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDe2356457-9791-3710-e053-2995a90ad1407
2166123dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 15 ML Oral SolutionSYe2356457-9791-3710-e053-2995a90ad1407
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
69423-982-0669423098206177 mL in 1 BOTTLE, PLASTIC (69423-982-06) 177 ml2019-04-222026-12-31NoNoCurrent