Topcare Lice Killing

Product NDC: 36800-866
11-digit product format: 368000866
Labeler code: 36800
Product ID: 36800-866_772ef23b-b1f2-47f8-a829-5cc83ceacd46
Type: HUMAN OTC DRUG
Nonproprietary name: Piperonyl butoxide, Pyrethrum extract
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Topco Associates LLC
Application: part358G
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2007-09-05
Marketing end: 0000-00-00
Substance: PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
Active strength: 4 g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	36800-866		D	Discontinued by firm	2026-09-09
excluded package	package	36800-866	36800-866-16	D	Discontinued by firm	2026-09-09
excluded package	package	36800-866	36800-866-34	D	Discontinued by firm	2026-09-09

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-866-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-866-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-866-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-866-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-866-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-866-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-866-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-866-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-866-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-866-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-866-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-866-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-866-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-866-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-866-34	ML - Milliliter	36800-866	08805c8f-bf21-4948-9d0f-f25e7f899b6b	1	2020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PIPERONYL BUTOXIDE	ACTIVE INGREDIENT	LWK91TU9AH	TOPCARE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [TOPCO ASSOCIATES LLC]	2
PYRETHRUM EXTRACT	ACTIVE INGREDIENT	ZUM06L90GV	TOPCARE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [TOPCO ASSOCIATES LLC]	2
PIPERONYL BUTOXIDE	ACTIVE MOIETY	LWK91TU9AH	TOPCARE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [TOPCO ASSOCIATES LLC]	2
PYRETHRUM EXTRACT	ACTIVE MOIETY	ZUM06L90GV	TOPCARE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [TOPCO ASSOCIATES LLC]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	TOPCARE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [TOPCO ASSOCIATES LLC]	2
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	TOPCARE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [TOPCO ASSOCIATES LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [TOPCO ASSOCIATES LLC]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TOPCARE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [TOPCO ASSOCIATES LLC]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LWK91TU9AH	PIPERONYL BUTOXIDE	51-03-6	PIPERONYL BUTOXIDE
ZUM06L90GV	PYRETHRUM EXTRACT	8003-34-7	PYRETHRUM EXTRACT

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-866-34	36800086634	1 BOTTLE in 1 CARTON (36800-866-34) > 236 mL in 1 BOTTLE	1 bottle	2012-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Lice Killing Shampoo Drug Facts	Topco Associates LLC	2024-11-04	HUMAN OTC DRUG LABEL	7

Topcare Lice Killing

NDC auxiliary status#

Observed NDC auxiliary status history#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#