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 47 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLC51e34704-5e6b-4e80-836c-ddbc24a451b22026-03-06WarningsExact identifier
application number: M012
Medi-First Plus Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDESportpharm LLC20f58b0b-c123-477f-a62c-fa5423e23f932026-03-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLSportpharm LLC7f4e8d37-8c6b-4849-b86c-4335a0bcac1c2026-03-06WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and Flu KitDAYTIME AND NIGHTTIME COLD AND FLU KITAllegiant Health0533db78-7809-46ea-9998-deb5f6f1d0d92026-03-06WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLBetter Living Brands, LLC0153294d-7f52-4d92-8db8-daeca3e29a3b2026-03-06WarningsExact identifier
application number: M012
Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINMeijer Distribution, Inc.87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e2026-03-06WarningsExact identifier
application number: M012
RYNEX PEBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLEDWARDS PHARMACEUTICALS, INC.77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef2026-03-05WarningsExact identifier
application number: M012
Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)042f9449-4af0-4b15-bb3e-236afeb1e11f2026-03-05WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINAmerisource Bergen087a3a0b-8d3f-45ed-8807-0af47b446cac2026-03-05WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MGNUVICARE LLC6c4bc7d1-09d9-4311-8457-a1d47ab02a5a2026-03-05WarningsExact identifier
application number: M012
Allergy Relief childrensDIPHENHYDRAMINE HCLWALMART INC.dceb99a9-4aa3-4acc-b632-9a4ba8c879192026-03-04WarningsExact identifier
application number: M012
AMAZON Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAMAZON.COM SERVICES LLC26101105-a6cf-4b51-a639-9d078542fea32026-03-04WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLMajor Pharmaceuticals3a976e90-c6af-4414-984e-9987158c9e982026-03-04WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLBest Choice (Valu Merchandisers Company)714e93ec-0aa9-4be2-9311-399e82f148e02026-03-04WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)d1131759-dd2e-4c06-bb73-92dd975f55112026-03-04WarningsExact identifier
application number: M012
AMAZON Maximim Strength Adult Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAMAZON.COM SERVICES LLC6bbe8cc9-7a60-4476-b5cf-b13c5bebff262026-03-04WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5a1dfaf3-370d-4ac7-a72d-a48863a357412026-03-04WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyc5cb09d4-c049-461c-8898-2c5bb6a8a1382026-03-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC3d96d6d0-8c04-43bb-aed0-4cd00cdf34562026-03-04WarningsExact identifier
application number: M012
DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E Be2994c0f-add8-4f75-a6d2-24cd2af271e42026-03-03WarningsExact 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