Medicated

Product NDC
55319-100
11-digit product format
553190100
Labeler code
55319
Product ID
55319-100_c185f1bf-5c07-4671-ad3b-bb52f07cbe2a
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Eucalyptus Oil
Dosage form
CREAM
Route
TOPICAL
Labeler
Family Dollar Services Inc
Application
part348
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-07-19
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL
Active strength
5 g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-100IInactivated by FDA2026-10-16
excluded packagepackage55319-10055319-100-01IInactivated by FDA2026-10-16

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-100-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-100-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-100-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-100-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-100-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-100-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-100-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-100-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-100-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-100-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-100-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-100-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55319-100-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55319-100-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55319-100-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55319-100-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55319-100-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55319-100-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55319-100-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55319-100-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55319-100-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55319-100-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-100-012020-01-31C16284748780-19d75b9d0-9385-f424-e053-dadaa90a57ceMedicated chest rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-100-01MedicatedChest Rub113 g in 1 JARCREAM1132

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETMEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
EUCALYPTUS OILACTIVE INGREDIENT2R04ONI662MEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AMEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETMEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
EUCALYPTUS OILACTIVE MOIETY2R04ONI662MEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
MENTHOLACTIVE MOIETYL7T10EIP3AMEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
CEDAR LEAF OILINACTIVE INGREDIENTBJ169U4NLGMEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
NUTMEG OILINACTIVE INGREDIENTZ1CLM48948MEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEMEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
THYMOLINACTIVE INGREDIENT3J50XA376EMEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2
TURPENTINEINACTIVE INGREDIENTXJ6RUH0O4GMEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-100MEDICATED CHEST RUB (CAMPHOR, MENTHOL, EUCALYPTUS OIL) CREAM [FAMILY DOLLAR SERVICES INC]2Legacy NDC, 1 package rows20121130_6f8c45f2-8b47-4696-bd68-d327a48bb21b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55319-100-0155319010001113 g in 1 JAR113 gHistorical