Roota Re V for women

Product NDC: 54576-2001
11-digit product format: 545762001
Labeler code: 54576
Product ID: 54576-2001_63abf12b-aa96-4128-9098-5485a3f03532
Type: HUMAN OTC DRUG
Nonproprietary name: PANTHENOL
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Raphabio Inc
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2012-12-31
Marketing end: 0000-00-00
Substance: PANTHENOL
Active strength: 1 mg/240mL
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54576-2001		I	Inactivated by FDA		2026-09-09
excluded package	package	54576-2001	54576-2001-1	I	Inactivated by FDA		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 · 44 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	54576-2001-1	`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	54576-2001-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54576-2001-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54576-2001-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54576-2001-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54576-2001-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54576-2001-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54576-2001-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54576-2001-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54576-2001-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54576-2001-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54576-2001-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54576-2001-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54576-2001-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54576-2001-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54576-2001-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54576-2001-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54576-2001-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54576-2001-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54576-2001-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54576-2001-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54576-2001-1	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54576-2001-1	2019-11-27	C162847	48780-1	9855d018-e012-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54576-2001-1	Roota Re V for women	240 mL in 1 BOTTLE, WITH APPLICATOR	SHAMPOO	240		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTHENOL	ACTIVE INGREDIENT	WV9CM0O67Z	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
PANTHENOL	ACTIVE MOIETY	WV9CM0O67Z	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
ACORUS CALAMUS ROOT	INACTIVE INGREDIENT	XY1K7KIQ0F	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
CLOVE	INACTIVE INGREDIENT	K48IKT5321	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
FALLOPIA MULTIFLORA ROOT	INACTIVE INGREDIENT	AUZ3VD75MC	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
FIG	INACTIVE INGREDIENT	TGD87RII2U	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
GLYCERYL DISTEARATE	INACTIVE INGREDIENT	73071MW2KM	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
MORUS ALBA BARK	INACTIVE INGREDIENT	7O71A48NDP	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
PYRITHIONE ZINC	INACTIVE INGREDIENT	R953O2RHZ5	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
ROSA CANINA FRUIT OIL	INACTIVE INGREDIENT	CR7307M3QZ	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
ROSA CENTIFOLIA FLOWER OIL	INACTIVE INGREDIENT	H32V31VMWY	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
SODIUM LAUROYL SARCOSINATE	INACTIVE INGREDIENT	632GS99618	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
SOPHORA FLAVESCENS ROOT	INACTIVE INGREDIENT	IYR6K8KQ5K	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
SOY PROTEIN	INACTIVE INGREDIENT	R44IWB3RN5	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54576-2001	ROOTA RE V FOR WOMEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1	Legacy NDC, 1 package rows	20130105_226bef7a-74e2-4bc8-a31a-d558bedd5dca.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WV9CM0O67Z	PANTHENOL	16485-10-2	PANTHENOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54576-2001-1	54576200101	240 mL in 1 BOTTLE, WITH APPLICATOR	240 ml	Historical