FDA.reportPublic FDA data

TheraCare Medicated Chest Rub

Product NDC
71101-202
11-digit product format
711010202
Labeler code
71101
Product ID
71101-202_2994e1f7-7b1d-1e41-e063-6294a90a8a32
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol, eucalyptus oil
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Veridian Healthcare
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-01
Substance
EUCALYPTUS OIL; CAMPHOR (SYNTHETIC); MENTHOL
Active strength
.012; .048; .026 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
TheraCare Medicated Chest Rub
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EUCALYPTUS OIL.012 g/g
CAMPHOR (SYNTHETIC).048 g/g
MENTHOL.026 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2R04ONI662Internal UNII lookup
5TJD82A1ETInternal 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
727137Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7801843-f96c-710e-e053-6294a90a5086Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-202-01TheraCare Medicated Chest Rub100 g in 1 JAROINTMENT1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-202THERACARE MEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) OINTMENT [VERIDIAN HEALTHCARE]3Current NDC, 1 package rows20241220_f7801843-f96c-710e-e053-6294a90a5086.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 95 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care OriginalOXYMETAZOLINE HYDROCHLORIDESAFEWAY, INC.f7ad687b-dcaf-928c-e053-6294a90a6abe2025-10-16WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)90ccb29c-9967-46cb-a409-e440344e1a1a2025-10-15WarningsExact identifier
application number: M012
Robitussin Childrens Honey Day Night DM Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCf9999875-3433-4052-a628-39539d3732162025-10-15WarningsExact identifier
application number: M012
Robitussin Day and Night Cough Relief Value PackDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATEHaleon US Holdings LLC4029eccd-5443-4ae2-9232-2a1d922798f82025-10-15WarningsExact identifier
application number: M012
EndaCof DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.c68ea55a-8b9a-4a70-8b5c-1a27366518132025-10-15WarningsExact identifier
application number: M012
DURATUSS DMDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.413a3951-d704-f14b-e063-6394a90a06dc2025-10-15WarningsExact identifier
application number: M012
LoHist DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.29730dab-fa09-4351-9b36-0359ba4f77442025-10-15WarningsExact identifier
application number: M012
M-END DMXDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDER. A. McNeil Companyee1fae2e-3a21-4487-9989-c7620a4a70562025-10-15WarningsExact identifier
application number: M012
Chlo TussCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDER.A. McNeil Company43610aaa-8b94-40d5-ae09-3d75bd2317c82025-10-15WarningsExact identifier
application number: M012
Chlo HistCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATER. A. McNeil Companyd046f4ba-5753-4ed5-a924-0b66fd1167812025-10-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)6ca7372b-50c4-4b15-b133-fefa35525ade2025-10-15WarningsExact identifier
application number: M012
Extra Strength Sinus Relief Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH0d8a009c-30b5-4f12-90bd-f8aa1110243f2025-10-14WarningsExact identifier
application number: M012
Tussin DM Cough plus Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCardinal Health 110, Inc. DBA LEADER9d11f443-c93d-44e8-b5a3-2677b7b112122025-10-14WarningsExact identifier
application number: M012
Rompe Pecho SFGUAIFENESINEfficient Laboratories, Inc.31ff48fc-9603-413c-ab7c-2598b3e08f9c2025-10-14WarningsExact identifier
application number: M012
Rompe Pecho DMDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Incd108c712-bc36-41d7-9ccd-720496b5599e2025-10-14WarningsExact identifier
application number: M012
Rompe Pechito DM for KidsDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc004d12e1-6e3d-84c8-e063-6394a90aa6532025-10-14WarningsExact identifier
application number: M012
VANACOF CP Allergy / CoughCHLOPHEDIANOL HCL, PYRILAMINE MALEATEGM Pharmaceuticals, INC0bdea30a-39da-6611-e063-6394a90aa4cf2025-10-14WarningsExact identifier
application number: M012
VANACOFCHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDEGM Pharmaceuticals, INCcf3886ab-62b3-497a-a587-18cbfbaf36342025-10-14WarningsExact identifier
application number: M012
Sugar Free Cherry Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.42d4bafb-b630-487e-b63d-13ad37a594542025-10-14WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc410c19f7-213d-cd99-e063-6294a90af5a32025-10-13WarningsExact 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 OintmentPSNf7801843-f96c-710e-e053-6294a90a50863
727137camphor 0.048 MG/MG / Eucalyptus oil 0.012 MG/MG / menthol 0.026 MG/MG Topical OintmentSCDf7801843-f96c-710e-e053-6294a90a50863
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Chest RubSYf7801843-f96c-710e-e053-6294a90a50863
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentSYf7801843-f96c-710e-e053-6294a90a50863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71101-202-0171101020201100 g in 1 JAR (71101-202-01) 100 g2023-03-01NoNoCurrent