CleanWell Natural Orange Vanilla Hand Sanitizer

Product NDC: 28107-008
11-digit product format: 281070008
Labeler code: 28107
Product ID: 28107-008_690df496-e8da-78f3-e053-2a91aa0aba80
Type: HUMAN OTC DRUG
Nonproprietary name: CleanWell Natural Orange Vanilla Hand Sanitizer
Dosage form: SPRAY
Route: TOPICAL
Labeler: CleanWell, LLC
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2007-11-01
Marketing end: 0000-00-00
Substance: THYMOL
Active strength: 0 kg/kg
NDC exclude flag: No
Listing certified through: 2019-12-31
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	28107-008		I	Inactivated by FDA		2026-08-17
excluded package	package	28107-008	28107-008-02	I	Inactivated by FDA		2026-08-17

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 · 42 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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`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	28107-008-02	`9bebd1f3094a…`	`5416666fcb17…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c599c4a0-705d-4ebb-ab1f-977af038f96a	Product name	1	20251124
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
28107-008-02	2020-01-31	C162847	48780-1	9d75b9d0-d45c-f424-e053-dadaa90a57ce	CleanWell Natural Orange Vanilla Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
28107-008-02	CleanWell Natural Orange Vanilla Hand Sanitizer	0.03 kg in 1 BOTTLE, SPRAY	SPRAY	0.03		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
THYMOL	ACTIVE INGREDIENT	3J50XA376E	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
THYMOL	ACTIVE MOIETY	3J50XA376E	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
AMINO ACIDS, OAT	INACTIVE INGREDIENT	NU3FAK86IP	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
COPPER	INACTIVE INGREDIENT	789U1901C5	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
DECANAL	INACTIVE INGREDIENT	31Z90Q7KQJ	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
OREGANO LEAF OIL	INACTIVE INGREDIENT	7D0CGR40U1	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
SODIUM COCO-SULFATE	INACTIVE INGREDIENT	3599J29ANH	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
SODIUM DECYLGLUCOSIDES HYDROXYPROPYLSULFONATE	INACTIVE INGREDIENT	55P9UXJ9C3	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
THYME OIL	INACTIVE INGREDIENT	2UK410MY6B	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
VANILLA PLANIFOLIA OIL	INACTIVE INGREDIENT	0A3F415158	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
28107-008	CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER SPRAY [CLEANWELL, LLC]	4	Legacy NDC, 1 package rows	20180405_675545a8-e2b3-428f-9d60-fd5419bdc97a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3J50XA376E	THYMOL	89-83-8	THYMOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1053171	thymol 0.05 % Topical Spray	PSN	675545a8-e2b3-428f-9d60-fd5419bdc97a	4
1053171	thymol 0.5 MG/ML Topical Spray	SCD	675545a8-e2b3-428f-9d60-fd5419bdc97a	4
1053171	thymol 0.05 % Topical Spray	SY	675545a8-e2b3-428f-9d60-fd5419bdc97a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
28107-008-02	28107000802	0.03 kg in 1 BOTTLE, SPRAY	0.03 kg	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CleanWell Natural Orange Vanilla Hand Sanitizer	CleanWell, LLC \| Precise Packaging LLC	2018-04-04	HUMAN OTC DRUG LABEL	4