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 99 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPSMENTHOLR.L. ALBERT & SON, INCc6b36350-386b-4346-bef0-a37ec11319c02025-10-08WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC3314b174-d5bb-4843-9288-9b9c5fce79d52025-10-08WarningsExact identifier
application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral SolutionDIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.407b7cbb-7ebd-7b7e-e063-6394a90af5012025-10-06WarningsExact identifier
application number: M012
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc2025-10-06WarningsExact identifier
application number: M012
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC2b19fdd2-8088-47f2-be20-f220a6b825fc2025-10-06WarningsExact identifier
application number: M012
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc40802fb6-c1ec-d7b0-e063-6394a90ab4232025-10-06WarningsExact identifier
application number: M012
Giltuss DiabeticDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc3f64c81a-bbfc-4575-e063-6294a90a6ed72025-10-06WarningsExact identifier
application number: M012
TexaClear Severe Cough, Cold and FluCHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGM Pharmaceuticals, INCcb99e5b3-1908-43c9-b31f-d35e7ce58b442025-10-06WarningsExact identifier
application number: M012
RoboHBr Cough SUPPRESSANTDEXTROMETHORPHAN HBRDXM Pharmaceutical, Inc0af624ce-191f-45e1-882b-e8acb90cc77b2025-10-06WarningsExact identifier
application number: M012
RoboTabletsDEXTROMETHORPHANDXM Pharmaceutical, Incb92cf698-032d-4d8d-b19c-456c6338b0942025-10-06WarningsExact identifier
application number: M012
SinuLiefLORATADINERoseWell Pharmaceuticals LLC32619143-a782-3497-e063-6394a90aaaec2025-10-06WarningsExact identifier
application number: M012
STAHIST ADCHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEMagna Pharmaceuticals, Inc.ccedbc38-2479-4c35-9f86-a9f29bcfab3f2025-10-03WarningsExact identifier
application number: M012
Childrens PediaClear 8PYRILAMINE MALEATEGM Pharmaceuticals, INC8e524967-d01c-4c93-9198-c42f15fe3fe02025-10-03WarningsExact identifier
application number: M012
Childrens PediaClear PDTRIPROLIDINE HYDROCHLORIDEGM Pharmaceuticals, INCf3ede5b7-1b0f-493a-b647-4459affc7e542025-10-03WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEInvaTech Pharma Solutions LLC40288ecf-043d-eb9e-e063-6394a90ac0a72025-10-02WarningsExact identifier
application number: M012
Guaifenesin 400GUAIFENESIN TABLETS 400InvaTech Pharma Solutions LLC40291505-55ca-0759-e063-6394a90acee12025-10-02Exact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3dd5b783-5b64-24b5-e063-6394a90ab4ee2025-10-02WarningsExact identifier
application number: M012
Acetaminophen and Diphenhydramine citrateACETAMINOPHEN AND DIPHENHYDRAMINE CITRATEInvaTech Pharma Solutions LLC403a88fa-e06b-9b6e-e063-6394a90a97b82025-10-02WarningsExact identifier
application number: M012
Equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEUnited Natural Foods, Inc. dba UNFI3053f6d7-0eff-488c-8901-770dcc62af062025-10-02WarningsExact identifier
application number: M012
Rompe Pecho CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDextrum Laboratories, Inc401a97af-36ae-4e54-e063-6294a90ab3ee2025-10-01WarningsExact 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