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 107 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERite Aid Corporation5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a02025-08-18WarningsExact identifier
application number: M012
MAJOR NASAL DECONGESTANTOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutions4b78b9af-0975-43f8-8b44-daddef0478be2025-08-15WarningsExact identifier
application number: M012
Dr Simi Mucus Relief ExpectorantGUAIFENESINFarmacias De Similares TX LLC3c6d0e75-a685-6020-e063-6294a90a5c1b2025-08-15WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation25bf4390-23f7-4bb6-b86e-c40eaf8d92da2025-08-15WarningsExact identifier
application number: M012
Childrens Chewable Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2cac72be-4830-ad49-e063-6394a90a78322025-08-14WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTHDEXTROMETHORPHAN HBR AND GUAIFENESINAMERISOURCE BERGEN2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e2025-08-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalmart Inc.16fae164-28db-8ef1-e063-6294a90ab5da2025-08-12WarningsExact identifier
application number: M012
Exchange Select Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fbece335-a7e5-4732-a086-561b237415792025-08-12WarningsExact identifier
application number: M012
MGC Health Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.779ddb89-b6e2-4bfb-bcb5-8c7ec916675a2025-08-12WarningsExact identifier
application number: M012
Equaline NasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFId7fa1720-eac4-4e82-9401-77215ce4f5452025-08-12WarningsExact identifier
application number: M012
Diabetic Tussin DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINMEDTECH PRODUCTS INCa10a3b33-7503-4334-8ed7-2bb881df43272025-08-08WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health, Inc26a55d74-f772-5d17-e063-6394a90a55832025-08-07WarningsExact identifier
application number: M012
Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E Bb7434978-44a8-4c51-979d-0bc446461e432025-08-06WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacyfc1e224c-5c57-43fc-ae6e-36aa0a4ae4392025-08-06WarningsExact identifier
application number: M012
childrens cold cough dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPublix Super Markets Inc6efe7097-2a99-4654-9d94-b47f2e64d19d2025-08-05WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINChain Drug Marketing Association, Inc.3b7548ee-7cd3-62c3-e063-6294a90a06122025-08-03WarningsExact identifier
application number: M012
Vaporizing chest rubCAMPHOR, EUCALYPTUS OIL, MENTHOLLJ Pharma065bb666-e482-4e96-ac75-c6577dcc5b482025-08-01WarningsExact identifier
application number: M012
Nighttime Cough-KidsCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGenexa024bb864-4214-1d8b-e063-6394a90aa5732025-08-01WarningsExact identifier
application number: M012
Antigrip Cough and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRPharmadel LLC3b53e5fc-f258-c2b9-e063-6394a90ab5002025-08-01WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals1b591e27-b00b-41c8-9fe9-c633aba091342025-08-01WarningsExact 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