FDA.reportPublic FDA data

XtraCare Vaporizing Chest Rub

Product NDC
57337-051
11-digit product format
573370051
Labeler code
57337
Product ID
57337-051_126de448-c1db-40b7-e063-6394a90a96d2
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Rejoice International
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-30
Substance
CAMPHOR (NATURAL); MENTHOL
Active strength
5; 1 g/113g; g/113g
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
XtraCare Vaporizing Chest Rub
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)5 g/113g
MENTHOL1 g/113g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1487908Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3e220d6-fff4-452f-99a9-bd701fc608a0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-051-012024-02-28C16284748780-11030e365-052f-111a-e063-dadaa90a10e2XtraCare Vaporizing Chest Rub
57337-051-012024-01-30C16284748780-11030e365-052f-111a-e063-dadaa90a10e2XtraCare Vaporizing Chest Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-051-01XtraCare Vaporizing Chest Rub113 g in 1 BOTTLEGEL1135

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q941XTRACARE VAPORIZING CHEST RUB (CAMPHOR, MENTHOL) GEL [REJOICE INTERNATIONAL]3
MENTHOLACTIVE INGREDIENTL7T10EIP3AXTRACARE VAPORIZING CHEST RUB (CAMPHOR, MENTHOL) GEL [REJOICE INTERNATIONAL]3
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q941XTRACARE VAPORIZING CHEST RUB (CAMPHOR, MENTHOL) GEL [REJOICE INTERNATIONAL]3
MENTHOLACTIVE MOIETYL7T10EIP3AXTRACARE VAPORIZING CHEST RUB (CAMPHOR, MENTHOL) GEL [REJOICE INTERNATIONAL]3
CEDAR LEAF OILINACTIVE INGREDIENTBJ169U4NLGXTRACARE VAPORIZING CHEST RUB (CAMPHOR, MENTHOL) GEL [REJOICE INTERNATIONAL]3
NUTMEG OILINACTIVE INGREDIENTZ1CLM48948XTRACARE VAPORIZING CHEST RUB (CAMPHOR, MENTHOL) GEL [REJOICE INTERNATIONAL]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UXTRACARE VAPORIZING CHEST RUB (CAMPHOR, MENTHOL) GEL [REJOICE INTERNATIONAL]3
THYMOLINACTIVE INGREDIENT3J50XA376EXTRACARE VAPORIZING CHEST RUB (CAMPHOR, MENTHOL) GEL [REJOICE INTERNATIONAL]3
TURPENTINE OILINACTIVE INGREDIENTC5H0QJ6V7FXTRACARE VAPORIZING CHEST RUB (CAMPHOR, MENTHOL) GEL [REJOICE INTERNATIONAL]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-051XTRACARE VAPORIZING CHEST RUB (CAMPHOR, MENTHOL) GEL [REJOICE INTERNATIONAL]5Current NDC, Legacy NDC, 1 package rows20240229_c3e220d6-fff4-452f-99a9-bd701fc608a0.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 72 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DayTime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE04f9134e-1311-4843-90db-9244b9e61e1d2025-12-19WarningsExact identifier
application number: M012
Nighttime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE029e6215-b72d-4fd0-8918-db1abcc4490a2025-12-19WarningsExact identifier
application number: M012
DayTime and Nighttime Cold/Flu Relief Softgels - Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE5f680f37-b3db-450f-b8ca-f9e31a04dc042025-12-19WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLMarc Glassman, Inc.e916ef86-ca73-42dd-83dc-6033f56d96f22025-12-19WarningsExact identifier
application number: M012
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Marte243033b-6603-4c3e-a330-e7c7de51f69d2025-12-19WarningsExact identifier
application number: M012
CHILDRENS ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart6fa4f913-de83-4175-9dad-0dedab5b69a12025-12-19WarningsExact identifier
application number: M012
Day-Time COLD/FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLDiscount Drug Mart426db906-9aa4-448f-a361-09c1516efc252025-12-19WarningsExact identifier
application number: M012
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDiscount Drug Martf17385bc-82bb-4183-a4c9-067d8afb37572025-12-19WarningsExact identifier
application number: M012
MAXIUM STRENGTH DM MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDiscount Drug Mart9654fdcd-d660-471f-bc5d-aa7dead7a4a82025-12-19WarningsExact identifier
application number: M012
Night Time Multi-Symptom Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Mart8148c2b1-f6ec-4597-8e18-a6597cda57052025-12-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGNUVICARE LLC621ba20e-75c5-42fb-9692-7800f764c9782025-12-19WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCL 10 MGNUVICARE LLC4cde41dd-a0a7-45e7-aff3-ee9402dfdff22025-12-19WarningsExact identifier
application number: M012
COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2025-12-19WarningsExact identifier
application number: M012
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3df82c-1926-5238-e063-6294a90a7bbf2025-12-18WarningsExact identifier
application number: M012
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fac3425-32f0-38d6-e063-6394a90a6e7a2025-12-18WarningsExact identifier
application number: M012
NAFASOLINANAPHAZOLINE HYDROCHLORIDEDoral Pharmamedics Inc DBA AG Marin Pharmaceuticals30cade3d-208f-8594-e063-6394a90ad2a02025-12-18WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPArmy & Air Force Exchange Service20ac8a20-206c-0024-e063-6394a90a9d062025-12-18WarningsExact identifier
application number: M012
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPArmy & Air Force Exchange Service20ace10f-4257-b20e-e063-6394a90a3c7b2025-12-18WarningsExact identifier
application number: M012
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fabd782-14dc-1d1b-e063-6394a90af4282025-12-18WarningsExact identifier
application number: M012
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3c6b38-7236-899b-e063-6294a90aabde2025-12-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1487908camphor 4.8 % / menthol 1 % Topical GelPSNc3e220d6-fff4-452f-99a9-bd701fc608a05
1487908camphor 0.048 MG/MG / menthol 0.01 MG/MG Topical GelSCDc3e220d6-fff4-452f-99a9-bd701fc608a05
1487908camphor 4.8 % / menthol 1 % Topical GelSYc3e220d6-fff4-452f-99a9-bd701fc608a05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-051-0157337005101113 g in 1 BOTTLE (57337-051-01) 113 g2014-01-300000-00-00NoNoCurrent