Quality Choice Lice Killing

Product NDC: 63868-007
Requested package NDC: 63868-007-04
11-digit product format: 638680007
Labeler code: 63868
Product ID: 63868-007_b3efb6bb-bf3b-89f6-e053-2995a90a76c7
Type: HUMAN OTC DRUG
Nonproprietary name: Piperonyl butoxide, Pyrethrum extract
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Quality Choice
Application: part358G
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-10-28
Marketing end: 0000-00-00
Substance: PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
Active strength: 4 g/100mL; g/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63868-007	63868-007-04	I	Inactivated by FDA		2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-007-04	2025-01-30	C162847	48780-1	2cef2736-b311-d83d-e063-dadaa90ab31f	Lice Killing Shampoo Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-007-04	Quality Choice Lice Killing	1 in 1 CARTON	SHAMPOO	1		2
63868-007-04	Quality Choice Lice Killing	118 mL in 1 BOTTLE	SHAMPOO	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-007	QUALITY CHOICE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [QUALITY CHOICE]	2	Legacy NDC, 2 package rows	20201114_47f89d33-6e0c-4bb4-e054-00144ff88e88.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283219	piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated Shampoo	PSN	47f89d33-6e0c-4bb4-e054-00144ff88e88	2
283219	piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated Shampoo	SCD	47f89d33-6e0c-4bb4-e054-00144ff88e88	2
283219	piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated Shampoo	SY	47f89d33-6e0c-4bb4-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-007-04	63868000704	1 BOTTLE in 1 CARTON (63868-007-04) > 118 mL in 1 BOTTLE	1 bottle	2014-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lice Killing Shampoo Drug Facts	Quality Choice \| Weeks & Leo Co., Inc.	2020-11-12	HUMAN OTC DRUG LABEL	2