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 121 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UP AND UP NO DRIP NASALOXYMETAZOLINE HYDROCHLORIDETarget Corporation760d6d0f-00fc-40bc-858d-83a0827d139f2025-01-29WarningsExact identifier
application number: M012
Guaifenesin and DextromethorphanGUAIFENESIN AND DEXTROMETHORPHANMajor Pharmaceuticals51e48201-bb62-4e89-85eb-e4a416f935222025-01-29WarningsExact identifier
application number: M012
Severe Congestion and Cough MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice8c878e47-94f4-484f-bdd8-6d87ac2440d82025-01-28WarningsExact identifier
application number: M012
Cough and Cold TherapyCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088be461-7afc-586a-e063-6294a90a700b2025-01-27WarningsExact identifier
application number: M012
Cough and Cold Therapy For KidsCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088df369-114c-db4f-e063-6394a90acfac2025-01-27WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a2025-01-26WarningsExact identifier
application number: M012
Walgreens Menthol Cough DropsMENTHOLWalgreens2c62f690-8dfb-d28e-e063-6394a90a45a22025-01-23WarningsExact identifier
application number: M012
Walgreens Cherry Cough DropsMENTHOLWalgreens2c65d836-e724-50d6-e063-6394a90a08272025-01-23WarningsExact identifier
application number: M012
Walgreens Honey Lemon Cough DropsMENTHOLWalgreens2c67424c-2fb0-cc15-e063-6394a90a02ca2025-01-23WarningsExact identifier
application number: M012
Pharmacys Prescription Analgesic GelMENTHOLAmerican Consumer Products Corp6f0725f2-833f-f3a0-e053-2a91aa0a39112025-01-23WarningsExact identifier
application number: M012
Pharmacys Prescription Vapor RubMENTHOLAmerican Consumer Products Corp6ef328ff-f5c3-515d-e053-2a91aa0a32d32025-01-23WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLBest Choice0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d2025-01-22WarningsExact identifier
application number: M012
GOOD REMEDIES Allergy Relief SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.26a02737-2cfd-769f-e063-6394a90af3522025-01-22WarningsExact identifier
application number: M012
PharbechlorCHLORPHENIRAMINE MALEATE 4MGUlai Health LLC6a1a5cef-e946-4ba8-9402-557c6adf45f92025-01-20WarningsExact identifier
application number: M012
PharbinexGUAIFENESIN 400MGUlai Health LLC4eafa81a-aeee-4c97-85d6-594902b109192025-01-20Exact identifier
application number: M012
Pharbinex-PEGUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MGUlai Health LLCe459bb83-b1d6-42fc-aa46-99ad117e61442025-01-20Exact identifier
application number: M012
Pharbinex-DMGUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MGUlai Health LLCaf80d10e-3fb2-405a-a803-1f876b8dcd102025-01-20Exact identifier
application number: M012
Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLBayer HealthCare LLC.34b2e77f-5d04-15a7-e054-00144ff8d46c2025-01-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange ZestASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a23a6db6-4585-2882-e053-2a95a90ab01a2025-01-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.fc754dff-cecd-fc6b-e053-6394a90ab3712025-01-17WarningsExact 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