Cocaine Hydrochloride

Product NDC
0527-1728
11-digit product format
005271728
Labeler code
0527
Product ID
0527-1728_094f1141-b41b-4ca0-bc04-6e9cca5df1c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cocaine Hydrochloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Lannett Company, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2008-12-01
Marketing end
2020-08-31
Substance
COCAINE HYDROCHLORIDE
Active strength
40 mg/mL
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0527-1728DDiscontinued by firm2026-08-17
excluded packagepackage0527-17280527-1728-73DDiscontinued by firm2026-08-17
excluded packagepackage0527-17280527-1728-74DDiscontinued by firm2026-08-17

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 · 36 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 packagepackage0527-1728-74d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0527-1728-73d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0527-1728-74f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0527-1728-73f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0527-1728-742ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0527-1728-732ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0527-1728-74a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0527-1728-73a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0527-1728-74cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0527-1728-73cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0527-1728-74cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0527-1728-73cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0527-1728-74302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0527-1728-73302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0527-1728-74ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0527-1728-73ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0527-1728-740efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0527-1728-730efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0527-1728-74ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0527-1728-73ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0527-1728-74367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0527-1728-73367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0527-1728-74557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0527-1728-73557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1728-73ML - Milliliter0527-172828fdc0b6-ba61-449c-a90f-eb95fb3c8ff712012-07-24
0527-1728-74ML - Milliliter0527-17289bdec9b9-04d1-4c44-b919-457154357bc412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCAINE HYDROCHLORIDEACTIVE INGREDIENTXH8T8T6WZHCOCAINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]9
COCAINEACTIVE MOIETYI5Y540LHVRCOCAINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]9
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCOCAINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCOCAINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]9
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCOCAINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]9
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOCAINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RCOCAINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.]9