Caladrox

Product NDC
54162-229
11-digit product format
541620229
Labeler code
54162
Product ID
54162-229_5977ea44-7dbe-476e-9691-421d2b5d14f6
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Geritrex LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-09-29
Marketing end
0000-00-00
Substance
MENTHOL; ZINC OXIDE
Active strength
0 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct54162-229IInactivated by FDA2026-10-05
excluded packagepackage54162-22954162-229-04IInactivated by FDA2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54162-229-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54162-229-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54162-229-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54162-229-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54162-229-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54162-229-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54162-229-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54162-229-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54162-229-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54162-229-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54162-229-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54162-229-04557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54162-229-048af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54162-229-04834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54162-229-041332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54162-229-04fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54162-229-0486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54162-229-04bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54162-229-048dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54162-229-04e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54162-229-049bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-229-042020-01-31C16284748780-19d75b9d0-7aa4-f424-e053-dadaa90a57ceCaladrox Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-229-04Caladrox113 g in 1 TUBEOINTMENT1131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-229-04GM - Gram54162-2295f4cfddc-7b44-47cb-81d5-b8f44b3ed7eb12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
MENTHOLACTIVE MOIETYL7T10EIP3ACALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37CALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
LANOLININACTIVE INGREDIENT7EV65EAW6HCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
PHENOLINACTIVE INGREDIENT339NCG44TVCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0CALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ACALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
THYMOLINACTIVE INGREDIENT3J50XA376ECALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-229CALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]1Legacy NDC, 1 package rows20151013_0fb20544-54bd-4f7a-8372-8a4dd1d79d21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
744868menthol 0.44 % / zinc oxide 20 % Topical OintmentPSN0fb20544-54bd-4f7a-8372-8a4dd1d79d211
744868menthol 0.0044 MG/MG / zinc oxide 0.2 MG/MG Topical OintmentSCD0fb20544-54bd-4f7a-8372-8a4dd1d79d211
744868Menthol 0.0044 MG/MG / ZNO 0.2 MG/MG Topical OintmentSY0fb20544-54bd-4f7a-8372-8a4dd1d79d211
744868menthol 0.44 % / zinc oxide 20 % Topical OintmentSY0fb20544-54bd-4f7a-8372-8a4dd1d79d211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54162-229-0454162022904113 g in 1 TUBE113 gHistorical