Occulus

Product NDC
13630-0092
11-digit product format
136300092
Labeler code
13630
Product ID
13630-0092_9c5c6bcc-c2b7-7c8b-e053-2995a90ad7f0
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Prime Packaging, Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-01
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct13630-0092IInactivated by FDA2026-10-20
excluded packagepackage13630-009213630-0092-3IInactivated by FDA2026-10-20

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 · 30 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 packagepackage13630-0092-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13630-0092-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13630-0092-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13630-0092-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13630-0092-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13630-0092-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13630-0092-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13630-0092-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13630-0092-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13630-0092-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13630-0092-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13630-0092-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13630-0092-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13630-0092-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13630-0092-31332a3947898…d4bfe170f9cd…

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
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0092-32024-01-30C16284748780-11030e365-55dd-111a-e063-dadaa90a10e233e56295-4edc-43fd-a937-1eeb32414fdb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0092-3OcculusSkin Hydrating Topical Foam CLO-1125 g in 1 CANAEROSOL, FOAM1253

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
CETEARYL ETHYLHEXANOATEINACTIVE INGREDIENT9M64UO4C25OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OOCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHOCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EOCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKOCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M46OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0092OCCULUS SKIN HYDRATING TOPICAL FOAM CLO-1 (CLOTRIMAZOLE) AEROSOL, FOAM [PRIME PACKAGING, INC.]3Legacy NDC, 1 package rows20200118_33e56295-4edc-43fd-a937-1eeb32414fdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299969clotrimazole 1 % Topical FoamPSN33e56295-4edc-43fd-a937-1eeb32414fdb3
1299969clotrimazole 10 MG/ML Topical FoamSCD33e56295-4edc-43fd-a937-1eeb32414fdb3
1299969clotrimazole 1 % Topical FoamSY33e56295-4edc-43fd-a937-1eeb32414fdb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0092-313630009203125 g in 1 CAN (13630-0092-3) 125 g2015-08-010000-00-00NoNoCurrent