FDA.reportPublic FDA data

Vicks VapoSteam

Product NDC
69901-522
11-digit product format
699010522
Labeler code
69901
Product ID
69901-522_d87250b4-5f54-4fd6-8848-4841fcf0285d
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor (synthetic)
Dosage form
LIQUID
Route
RESPIRATORY (INHALATION)
Labeler
Kaz USA, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-02-28
Substance
CAMPHOR (SYNTHETIC)
Active strength
.062 g/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69901-522-08UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69901-522-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69901-522-08IInactivated by FDAbd6a592717d7…303034d00443…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69901-522-08IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69901-522-08EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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 VapoSteam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).062 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
701961Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c28da455-07ad-4053-8b9e-fc559f9a3f72Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-04-14Vicks ® VapoSteam ®
2022-01-28Vicks ® VapoSteam ®
2020-09-18Vicks ® VapoSteam ®
2020-01-31Vicks ® VapoSteam ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69901-522-08Vicks VapoSteam1 in 1 CARTONLIQUID18
69901-522-08Vicks VapoSteam236 mL in 1 BOTTLE, PLASTICLIQUID2368

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Camphor (synthetic)ACTIVE INGREDIENT5TJD82A1ETVICKS VAPOSTEAM (CAMPHOR (SYNTHETIC)) LIQUID [KAZ USA, INC]1
camphor (synthetic)ACTIVE MOIETY5TJD82A1ETVICKS VAPOSTEAM (CAMPHOR (SYNTHETIC)) LIQUID [KAZ USA, INC]1
AlcoholINACTIVE INGREDIENT3K9958V90MVICKS VAPOSTEAM (CAMPHOR (SYNTHETIC)) LIQUID [KAZ USA, INC]1
Cedar Leaf OilINACTIVE INGREDIENTBJ169U4NLGVICKS VAPOSTEAM (CAMPHOR (SYNTHETIC)) LIQUID [KAZ USA, INC]1
Eucalyptus OilINACTIVE INGREDIENT2R04ONI662VICKS VAPOSTEAM (CAMPHOR (SYNTHETIC)) LIQUID [KAZ USA, INC]1
Laureth-7INACTIVE INGREDIENTZ95S6G8201VICKS VAPOSTEAM (CAMPHOR (SYNTHETIC)) LIQUID [KAZ USA, INC]1
Menthol, Unspecified FormINACTIVE INGREDIENTL7T10EIP3AVICKS VAPOSTEAM (CAMPHOR (SYNTHETIC)) LIQUID [KAZ USA, INC]1
Nutmeg OilINACTIVE INGREDIENTZ1CLM48948VICKS VAPOSTEAM (CAMPHOR (SYNTHETIC)) LIQUID [KAZ USA, INC]1
Poloxamer 124INACTIVE INGREDIENT1S66E28KXAVICKS VAPOSTEAM (CAMPHOR (SYNTHETIC)) LIQUID [KAZ USA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69901-522VICKS VAPOSTEAM (CAMPHOR (SYNTHETIC)) LIQUID [KAZ USA, INC]8Current NDC, Legacy NDC, 2 package rows20250116_c28da455-07ad-4053-8b9e-fc559f9a3f72.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 152 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCff433512-55b7-4fc9-8a55-aff5cbb749ef2024-10-11WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC3170354a-4752-49a0-97ed-3d9db266a0592024-10-11WarningsExact identifier
application number: M012
Tukol Children Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA235a6d2b-7302-410c-be35-4d5ff7bbdfce2024-10-11WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS Pharmacy6c7b0ea6-bff9-4fd2-9e00-64015c326ee82024-10-11WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Incdcc12bc2-4bb4-4d2d-8206-b9db9843ec8b2024-10-11WarningsExact identifier
application number: M012
Signature Care Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDESafeway838d2f11-2ee4-4081-98c8-b87e79aa47c42024-10-11WarningsExact identifier
application number: M012
MentholCOUGH SUPPRESSANTMcKesson9d4def70-480f-f2fa-e053-2995a90a98772024-10-10WarningsExact identifier
application number: M012
MentholCOUGH SUPPRESSANTMcKesson9d5b4ef6-4eb8-41f6-e053-2a95a90a13502024-10-10WarningsExact identifier
application number: M012
Tukol Sugar Free Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINGenomma Lab USA95e0a3eb-5a58-4c8b-a70b-fb0cca1e08412024-10-08WarningsExact identifier
application number: M012
Rompe Pecho CF CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06e96e0c-f21f-e706-e063-6294a90a07802024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.f9f0d020-e031-245e-e053-6294a90addb52024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7ee463-8003-a306-e053-6294a90a82592024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7e4a84-d2c2-65e5-e053-6394a90a0c722024-10-08WarningsExact identifier
application number: M012
Cough DropsCHERRYUnited Natural Foods, Inc.f9f0e853-6997-a49b-e053-6294a90aa4b82024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7fa728-911d-aaf0-e053-6394a90ace312024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f3b84-1e61-eadf-e053-6394a90a9e5c2024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f515f-7302-d153-e053-6394a90a08342024-10-08WarningsExact identifier
application number: M012
Rompe Pecho NT NTACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEEfficient Laboratories Inc06faafaa-50a6-c16e-e063-6294a90a49cb2024-10-08WarningsExact identifier
application number: M012
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRBryant Ranch Prepack8c25285e-e2cd-4e10-af63-5dce8098b6152024-10-08WarningsExact identifier
application number: M012
Severe Throat Sore DropsMENTHOLTarget Corporation Inc.949543d5-5043-ac06-e053-2995a90ab3982024-10-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
701961camphor 6.2 % Inhalation SolutionPSNc28da455-07ad-4053-8b9e-fc559f9a3f728
701961camphor 62 MG/ML Inhalation SolutionSCDc28da455-07ad-4053-8b9e-fc559f9a3f728
701961camphor 6.2 % Inhalation SolutionSYc28da455-07ad-4053-8b9e-fc559f9a3f728

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69901-522-08699010522081 BOTTLE, PLASTIC in 1 CARTON (69901-522-08) / 236 mL in 1 BOTTLE, PLASTIC1995-02-280000-00-00NoNoCurrent