FDA.reportPublic FDA data

Quality Choice Medicated Chest Rub

Product NDC
63868-800
11-digit product format
638680800
Labeler code
63868
Product ID
63868-800_43ce5d50-10e9-885d-e063-6394a90a3b96
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol, eucalyptus oil
Dosage form
OINTMENT
Route
TOPICAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-01
Marketing end
2028-07-31
Substance
EUCALYPTUS OIL; CAMPHOR (SYNTHETIC); MENTHOL
Active strength
.012; .048; .026 g/g; g/g; g/g
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct63868-800IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63868-80063868-800-04IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
Quality Choice Medicated Chest Rub

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
c0e3c959-bed6-2ce5-e053-2995a90a0be9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-800-042025-11-17C16284748780-13b156c62-24ae-fb37-e063-e6dba90a4e07Quality Choice Medicated Chest Rub
63868-800-042025-07-29C16284748780-13b156c62-24ae-fb37-e063-e6dba90a4e07Quality Choice Medicated Chest Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-800-04Quality Choice Medicated Chest Rub113 g in 1 JAROINTMENT1133

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-800-04GM - Gram63868-8003a5258c8-d9d1-430f-97f3-337883361b2c12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-800QUALITY CHOICE MEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) OINTMENT [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2Current NDC, Legacy NDC, 1 package rows20241220_c0e3c959-bed6-2ce5-e053-2995a90a0be9.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 136 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NightTime SinusACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.0f3b1404-9252-470a-aa8c-b360c85731f32024-11-25WarningsExact identifier
application number: M012
Maximum Strength-Cough and Chest Congestion DMMAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.d1830989-fe82-4f08-8618-78979fcef5682024-11-25WarningsExact identifier
application number: M012
ASP Daytime PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b84f2392-0b24-4af0-80f7-c45454093f512024-11-25WarningsExact identifier
application number: M012
ASP Nighttime MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.d8756d1f-baf5-412d-a493-a1c051eae3022024-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFOODHOLD U.S.A., LLC508a65ee-42fa-4c0b-b24d-9faac6b0eba72024-11-24WarningsExact identifier
application number: M012
DG Day Time Cold and Flu Formula and Night Time Cold and Flu FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLCcb68eef0-b027-4bf1-b78f-f31844a8c06c2024-11-22WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.de2a64ce-c169-4162-b79e-d3809bea21472024-11-22WarningsExact identifier
application number: M012
12 Hour Nasal Decongestant Extra MoisturizingNASAL SPRAYWinCo Foods LLC13fbde45-958c-455f-b766-f6a34342ee952024-11-21WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a01abac3-c13e-40f2-ae98-34bd6c9b75042024-11-21WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c62024-11-21WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.028b025e-2dde-4bef-ba7b-61774e855b4b2024-11-21WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC856cb3c3-8f32-4285-8c13-25f01779a31a2024-11-21WarningsExact identifier
application number: M012
Night Time Severe Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC3375a059-2939-438e-92b5-a7f1952bbb222024-11-21WarningsExact identifier
application number: M012
NiteTime Cold/Flu, Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc9033bf94-f444-4488-b717-050d04dee3882024-11-21WarningsExact identifier
application number: M012
Day and Night Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.4b554ce8-9a6a-444f-b5ea-63359bbc06532024-11-21WarningsExact identifier
application number: M012
Day Severe Cold and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.7492b381-9eca-4b07-b356-63fdaea14f812024-11-21WarningsExact identifier
application number: M012
Severe sinus Congestion ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLCe173bec9-14df-4535-a023-47d8cda8d4ec2024-11-21WarningsExact identifier
application number: M012
COLD FLU and SORE THROAT RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLC1161e5dc-0677-4fb9-964f-971a508098b62024-11-21WarningsExact identifier
application number: M012
Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERetail Business Services, LLCfc8c70d6-6be5-4f12-84b0-125fc82149ec2024-11-21WarningsExact identifier
application number: M012
12 Hour Original Nasal DecongestantNASAL SPRAYWinCo Foods LLCb3b6065a-56da-45e9-b89d-f6553bc181c92024-11-21WarningsExact 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 OintmentPSNc0e3c959-bed6-2ce5-e053-2995a90a0be93
727137camphor 0.048 MG/MG / Eucalyptus oil 0.012 MG/MG / menthol 0.026 MG/MG Topical OintmentSCDc0e3c959-bed6-2ce5-e053-2995a90a0be93
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Chest RubSYc0e3c959-bed6-2ce5-e053-2995a90a0be93
727137camphor 4.8 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentSYc0e3c959-bed6-2ce5-e053-2995a90a0be93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-800-0463868080004113 g in 1 JAR (63868-800-04) 113 g2021-04-012028-07-31NoNoCurrent