AVERTEAX

Product NDC
54866-001
11-digit product format
548660001
Labeler code
54866
Product ID
54866-001_274fa9e5-6f94-4ac3-b952-0a7fdeebad45
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide and Cocoa Butter
Dosage form
CREAM
Route
TOPICAL
Labeler
Camellix, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
ZINC OXIDE; COCOA BUTTER
Active strength
0 mg/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct54866-001IInactivated by FDA2026-10-12
excluded packagepackage54866-00154866-001-01IInactivated by FDA2026-10-12

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 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 packagepackage54866-001-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54866-001-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54866-001-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54866-001-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54866-001-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54866-001-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54866-001-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54866-001-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54866-001-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54866-001-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54866-001-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54866-001-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54866-001-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54866-001-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54866-001-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54866-001-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54866-001-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54866-001-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54866-001-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54866-001-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54866-001-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54866-001-01110d247fa046…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
54866-001-012019-11-27C16284748780-19855e2a2-44e2-60a7-e053-dbdaa90a05bdAVERTEX Zinc Oxide, Cocoa Butter

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54866-001-01AVERTEAX4.2 g in 1 TUBECREAM4.21
54866-001-01AVERTEAX1 in 1 PACKAGECREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
COCOA BUTTERACTIVE MOIETY512OYT1CRRAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1AVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9AVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
EPIGALLOCATECHIN GALLATE PALMITATESINACTIVE INGREDIENTM213AC47MBAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
EPIGALLOCATECHIN GALLATE STEARATESINACTIVE INGREDIENTMGB2NQG22CAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662AVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
Royal JellyINACTIVE INGREDIENTL497I37F0CAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXAAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VAVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54866-001AVERTEAX (ZINC OXIDE AND COCOA BUTTER) CREAM [CAMELLIX, LLC]1Legacy NDC, 2 package rows20140507_1e5ea5fd-4394-4b7c-bcbc-6c443d1135d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536212Averteax Lip Protector (cocoa butter 0.25 % / Zinc Oxide 0.15 % ) Topical CreamPSN1e5ea5fd-4394-4b7c-bcbc-6c443d1135d71
1536207cocoa butter 0.25 % / zinc oxide 0.015 % Topical CreamPSN1e5ea5fd-4394-4b7c-bcbc-6c443d1135d71
1536212cocoa butter 2.5 MG/ML / zinc oxide 0.15 MG/ML Topical Cream [Averteax Lip Protector]SBD1e5ea5fd-4394-4b7c-bcbc-6c443d1135d71
1536207cocoa butter 2.5 MG/ML / zinc oxide 0.15 MG/ML Topical CreamSCD1e5ea5fd-4394-4b7c-bcbc-6c443d1135d71
1536212Averteax Lip Protector (cocoa butter 0.25 % / Zinc Oxide 0.15 % ) Topical CreamSY1e5ea5fd-4394-4b7c-bcbc-6c443d1135d71
1536207cocoa butter 2.5 MG/ML / ZNO 0.15 MG/ML Topical CreamSY1e5ea5fd-4394-4b7c-bcbc-6c443d1135d71
1536212cocoa butter 2.5 MG/ML / ZNO 0.15 MG/ML Topical Cream [Averteax Lip Protector]SY1e5ea5fd-4394-4b7c-bcbc-6c443d1135d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54866-001-01548660001014.2 g in 1 TUBE4.2 gHistorical