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 75 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Mucus Relief Cough Cherry LiquidDEXTROMETHORPHAN HBR, GUAIFENSINTopco Associates3170748e-b09f-4c07-9927-df43771166c52025-12-16WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe2025-12-16WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)e70d0784-53bc-4910-aade-3c9ad6e364412025-12-16WarningsExact identifier
application number: M012
Pain and SinusACETAMINOPHEN AND PHENYLEPHRINEJHK Inc dba American Safety & First Aid88f86f5a-cc2b-4c75-b7a4-f2021922280b2025-12-16WarningsExact identifier
application number: M012
Severe Congestion and Cough, Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Companyb75af815-9bd4-4a7a-bc68-f42f4af506992025-12-16WarningsExact identifier
application number: M012
Cough Relief NighttimeDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fe5fd29e-7f81-4633-8c3b-010d68abe7012025-12-16WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLCe0a62fa1-9f8a-4770-b28b-1f4f02a762e02025-12-16WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company8c4b59b8-dfab-4f4a-9966-f07b026a758a2025-12-16WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)df866cf6-0526-4e61-ac9b-245b57dd5df62025-12-16WarningsExact identifier
application number: M012
Severe Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensc89200b6-4adb-452e-b931-07f631dad6412025-12-16WarningsExact identifier
application number: M012
ONESSIP ADULT DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIMEDWISE LIFESCIENCES INC.45fa9159-d74c-063a-e063-6294a90a3ed02025-12-15WarningsExact identifier
application number: M012
SudoGest Nasal DecongestantPSEUDOEPHEDRINE HCLMajor Pharmaceuticals5229f4b2-a194-46f8-a0bc-4510fbe520752025-12-15WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCf2b2467f-2d9b-4742-b90a-95975c3b694f2025-12-13WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLHEB39178eb7-ada9-30bf-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
SF Menthol Cough DropMENTHOLHEB3a443179-b7a6-3242-e054-00144ff8d46c2025-12-13WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLHEB39bd0ca1-348f-0ce1-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
Strawberry Cough DropsMENTHOLHEB766236e2-3302-2232-e053-2991aa0af5032025-12-13WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLHEB3a30a427-6ab4-24ae-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
Mixed Berry Sore Throat and Cough LozengesBENZOCAINEHEB3063ea93-6bc2-1d18-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
HEB Menthol Cough DropsMENTHOLHEBc197855d-15b4-38fc-e053-2a95a90a2dc72025-12-13WarningsExact 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