FDA.reportPublic FDA data

Vicks VapoRub ADVANCED PLUS

Product NDC
64336-001
11-digit product format
643360001
Labeler code
64336
Product ID
64336-001_5d19409b-a118-f014-e063-6394a90abe58
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Eucalyptus oil, Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Procter & Gamble Manufacturing GmbH
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-06
Substance
EUCALYPTUS OIL; MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC)
Active strength
.012; .026; .048 g/g; g/g; g/g
NDC exclude flag
No
Listing certified through
2027-12-31
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 VapoRub ADVANCED PLUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EUCALYPTUS OIL.012 g/g
MENTHOL, UNSPECIFIED FORM.026 g/g
CAMPHOR (SYNTHETIC).048 g/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64336-001-01Vicks VapoRub ADVANCED PLUS1 in 1 CARTONOINTMENT18
64336-001-01Vicks VapoRub ADVANCED PLUS50 g in 1 JAROINTMENT508
64336-001-02Vicks VapoRub ADVANCED PLUS1 in 1 CARTONOINTMENT18
64336-001-02Vicks VapoRub ADVANCED PLUS80 g in 1 JAROINTMENT808
64336-001-03Vicks VapoRub ADVANCED PLUS80 g in 1 JAROINTMENT808
64336-001-03Vicks VapoRub ADVANCED PLUS2 in 1 CELLO PACKOINTMENT28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64336-001VICKS VAPORUB ADVANCED PLUS (CAMPHOR, EUCALYPTUS OIL, MENTHOL) OINTMENT [PROCTER & GAMBLE MANUFACTURING GMBH]7Current NDC, 6 package rows20241012_f801128c-94bb-fa9e-e053-6294a90a0822.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 24 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allegra Allergy 24 hourFEXOFENADINE HYDROCHLORIDESelect Consumer Group2de81a41-8488-7e39-e063-6294a90a394b2026-06-01WarningsExact identifier
application number: M012
Cough and Runny Nose Childrens PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDETOP CARE (Topco Associates LLC)6f04bd51-093c-4624-aef3-0145ac3873862026-06-01WarningsExact identifier
application number: M012
NasalPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy694a3116-1b75-42cd-bbcf-d19831c2d7962026-06-01WarningsExact identifier
application number: M012
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E Bcf31538c-9eee-4c81-80cb-66eecabf0aff2026-06-01WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC155e07b3-0a08-3be8-e063-6394a90a76352026-05-31WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough NighttimeDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC156033ae-b16a-007b-e063-6294a90a74452026-05-31WarningsExact identifier
application number: M012
Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyebf8c82d-a653-4c02-893b-61704901acbb2026-05-29WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLAmerisource Bergen934c7b91-3cba-47f0-8efa-77216f3f15c42026-05-29WarningsExact identifier
application number: M012
Allergy MedicineDIPHENHYDRAMINE HCLCOSTCO WHOLESALE CORPORATIONd9f03e11-d11f-43ee-8ed0-9e07d1058f662026-05-29WarningsExact identifier
application number: M012
Cold Childrens, Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYeaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d2026-05-29WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC3598ac5b-29f9-f002-e063-6294a90a62cb2026-05-28WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC51badd2f-4a43-3dbe-e063-6294a90a4bd12026-05-28WarningsExact identifier
application number: M012
Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.a7ab2140-de09-158f-e053-2a95a90a25a02026-05-28WarningsExact identifier
application number: M012
Kids Multi Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.2d918ec8-3098-1d09-e063-6294a90a9e8f2026-05-28WarningsExact identifier
application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLGenexa Inc.213fe898-dace-9a0f-e063-6394a90afd642026-05-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey Lemon FlavorMENTHOLMedical Group Care LLC556628ab-e233-92fe-e063-6394a90a00902026-05-28WarningsExact identifier
application number: M012
Sinus Decongestion PEPHENYLEPHRINE HCLKroger Company68eff734-177e-4999-9126-6b92bb2041072026-05-28WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRARMY AND AIR FORCE EXCHANGE SERVICEff39084f-ab2f-48ed-ac62-837f7fff2b652026-05-28WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo PackDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC16637d54-8049-d3ce-e063-6394a90aafc92026-05-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentPSNf801128c-94bb-fa9e-e053-6294a90a08228
727137camphor 0.048 MG/MG / Eucalyptus oil 0.012 MG/MG / menthol 0.026 MG/MG Topical OintmentSCDf801128c-94bb-fa9e-e053-6294a90a08228
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Chest RubSYf801128c-94bb-fa9e-e053-6294a90a08228
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentSYf801128c-94bb-fa9e-e053-6294a90a08228

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64336-001-01643360001011 JAR in 1 CARTON (64336-001-01) / 50 g in 1 JAR1 jar2023-07-06NoNoCurrent
64336-001-02643360001021 JAR in 1 CARTON (64336-001-02) / 80 g in 1 JAR1 jar2023-07-06NoNoCurrent
64336-001-03643360001032 JAR in 1 CELLO PACK (64336-001-03) / 80 g in 1 JAR2 jar2023-07-06NoNoCurrent