AT ONE WITH NATURE

Product NDC: 54602-758
11-digit product format: 546020758
Labeler code: 54602
Product ID: 54602-758_3398bb40-df14-494e-9e1f-619629b94979
Type: HUMAN OTC DRUG
Nonproprietary name: PYRITHIONE ZINC
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: BIOCARE LABS INC.
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2009-01-20
Marketing end: 0000-00-00
Substance: PYRITHIONE ZINC
Active strength: 10 mg/mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54602-758		I	Inactivated by FDA	2026-10-12
excluded package	package	54602-758	54602-758-08	I	Inactivated by FDA	2026-10-12
excluded package	package	54602-758	54602-758-16	I	Inactivated by FDA	2026-10-12

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 2 · 66 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	54602-758-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54602-758-08	`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	54602-758-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54602-758-08	`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	54602-758-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54602-758-08	`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	54602-758-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54602-758-08	`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	54602-758-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54602-758-08	`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	54602-758-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54602-758-08	`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	54602-758-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54602-758-08	`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	54602-758-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54602-758-08	`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	54602-758-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54602-758-08	`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	54602-758-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54602-758-08	`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	54602-758-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54602-758-08	`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	54602-758-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54602-758-08	`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	54602-758-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54602-758-08	`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	54602-758-16	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54602-758-08	`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	54602-758-16	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54602-758-08	`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	54602-758-16	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54602-758-08	`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	54602-758-16	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54602-758-08	`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	54602-758-16	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54602-758-08	`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	54602-758-16	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54602-758-08	`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	54602-758-16	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54602-758-08	`e2bbac7714bc…`	`27bdfed8d636…`

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
54602-758-08	2019-11-27	C162847	48780-1	9855d018-ef12-cd31-e053-dbdaa90ab51a	48da6e99-10d3-41fe-9e56-9dd98568dd7d
54602-758-16	2019-11-27	C162847	48780-1	9855d018-ef12-cd31-e053-dbdaa90ab51a	48da6e99-10d3-41fe-9e56-9dd98568dd7d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54602-758-08	AT ONE WITH NATUREDRY AND ITCHY SCALP	237 mL in 1 BOTTLE	SHAMPOO	237		1
54602-758-16	AT ONE WITH NATUREDRY AND ITCHY SCALP	473 mL in 1 BOTTLE	SHAMPOO	473		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
AMMONIUM LAURETH-2 SULFATE	INACTIVE INGREDIENT	698O4Z48G6	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
AMMONIUM LAURYL SULFATE	INACTIVE INGREDIENT	Q7AO2R1M0B	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
ARGAN OIL	INACTIVE INGREDIENT	4V59G5UW9X	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
CENTAUREA CYANUS FLOWER	INACTIVE INGREDIENT	QZ239038YC	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
CHAMAEMELUM NOBILE FLOWER	INACTIVE INGREDIENT	O2T154T6OG	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE	INACTIVE INGREDIENT	1R81RPY10G	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
GARLIC	INACTIVE INGREDIENT	V1V998DC17	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
GLYCOL STEARATE	INACTIVE INGREDIENT	0324G66D0E	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
HEDERA HELIX LEAF	INACTIVE INGREDIENT	ZP9XFG71A7	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
HYPERICUM PERFORATUM	INACTIVE INGREDIENT	XK4IUX8MNB	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
LAMIUM ALBUM	INACTIVE INGREDIENT	046Y1357I6	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
NASTURTIUM OFFICINALE FLOWERING TOP	INACTIVE INGREDIENT	W1N2U8I64G	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
PINE NEEDLE OIL (PINUS SYLVESTRIS)	INACTIVE INGREDIENT	5EXL5H740Y	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
POLYQUATERNIUM-28 (1100000 MW)	INACTIVE INGREDIENT	6M8B654MEQ	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
TILIA CORDATA FLOWER	INACTIVE INGREDIENT	CFN6G1F6YK	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54602-758	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1	Legacy NDC, 2 package rows	20121229_48da6e99-10d3-41fe-9e56-9dd98568dd7d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R953O2RHZ5	PYRITHIONE ZINC	13463-41-7	PYRITHIONE ZINC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	48da6e99-10d3-41fe-9e56-9dd98568dd7d	1
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	48da6e99-10d3-41fe-9e56-9dd98568dd7d	1
209884	zinc pyrithione 1 % Medicated Conditioner	SY	48da6e99-10d3-41fe-9e56-9dd98568dd7d	1
209884	zinc pyrithione 1 % Medicated Shampoo	SY	48da6e99-10d3-41fe-9e56-9dd98568dd7d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54602-758-08	54602075808	237 mL in 1 BOTTLE	237 ml	Historical
54602-758-16	54602075816	473 mL in 1 BOTTLE	473 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AT ONE WITH NATURE DRY AND ITCHY SCALP - BIOCARE LABS INC. \| RAANI CORPORATION	BIOCARE LABS INC. \| RAANI CORPORATION	2012-12-27	HUMAN OTC DRUG LABEL	1