FDA.reportPublic FDA data

Vicks childrens

Product NDC
37000-712
11-digit product format
370000712
Labeler code
37000
Product ID
37000-712_4df603a4-0a44-635c-e063-6394a90a37dd
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride and Diphenhydramine Hydrochloride
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
DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
12.5; 5 mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Night

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87231460-8b45-b995-e053-2a91aa0a6c43Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-02-12VICKS ® children's Cough Congestion Night
2021-02-12VICKS ® children's Cough Congestion Night
2021-01-29VICKS ® children's Cough Congestion Night
2021-01-29VICKS ® children's Cough Congestion Night

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-712-06Vicks childrensCough Congestion Night177 mL in 1 BOTTLE, PLASTICLIQUID17711
37000-712-06VICKS 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
37000-712VICKS CHILDRENS COUGH CONGESTION NIGHT (PHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Current NDC, Legacy NDC, 1 package rows20241012_87231460-8b45-b995-e053-2a91aa0a6c43.zip
37000-712VICKS 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 73 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREEMENTHOLChain Drug Marketing Association, Inc.8f6ee01c-baad-489f-b2fd-0ef506916ee42025-12-18WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLMeijer5baeaff7-172c-187a-e053-2a91aa0ab1652025-12-18WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLMeijer Distribution Inc.3bee752a-4141-1f5b-e054-00144ff8d46c2025-12-18WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLMeijer5bc2ec81-a3cb-3a59-e053-2a91aa0ac14e2025-12-18WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLMeijer5bc3b9b8-e61e-1041-e053-2a91aa0a3d832025-12-18WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLMeijer5bd35bce-cd85-5314-e053-2991aa0abce62025-12-18WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLMeijer5bd42654-56e5-997e-e053-2a91aa0afd342025-12-18WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLMeijer5bd61cd4-a5ca-9d66-e053-2a91aa0a93a32025-12-18WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLMeijer5bd7c24d-6a61-5d2d-e053-2a91aa0a08ed2025-12-18WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropsMENTHOLMeijer Distribution70e3de9a-1804-ef15-e053-2a95a90a33402025-12-18WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Vanilla HoneyMENTHOLChain Drug Marketing Association, Inc.3d6a4bcc-1044-40f5-928a-378ececcb6872025-12-18WarningsExact identifier
application number: M012
Meijer Strawberry Cough DropsMENTHOLMeijer164de637-e644-711c-e063-6294a90a1c5f2025-12-18WarningsExact identifier
application number: M012
Meijer Severe Menthol Throat DropsMENTHOLMeijer16603ca4-1ce5-2e7e-e063-6394a90ad6f12025-12-18WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLA-S Medication Solutions60587987-c303-4617-ba96-c518ab2a06502025-12-18WarningsExact identifier
application number: M012
NiafluDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC399898f0-e40a-4f5d-e063-6294a90a667d2025-12-17WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLThe Kroget Co.4313a6ce-454d-4c4b-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Menthol cough dropMENTHOLThe Kroger Co.42b257e9-f45e-32c9-e054-00144ff8d46c2025-12-17WarningsExact identifier
application number: M012
Honey Lemon cough dropMENTHOLThe Kroger Co.4318f25a-05d9-2208-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Honey Lemon cough dropMENTHOLThe Kroger Co.4317f952-a228-0281-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLThe Kroger Co.4316df6e-3ae6-4ab5-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2166129diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN87231460-8b45-b995-e053-2a91aa0a6c4311
2166129diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD87231460-8b45-b995-e053-2a91aa0a6c4311
2166129diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 15 ML Oral SolutionSY87231460-8b45-b995-e053-2a91aa0a6c4311
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, PLASTIC (37000-712-06) 177 ml2019-04-222026-12-31NoNoCurrent