Bioelements

Product NDC: 49825-113
11-digit product format: 498250113
Labeler code: 49825
Product ID: 49825-113_87645f39-f53a-463a-b956-e4172f3ecdb2
Type: HUMAN OTC DRUG
Nonproprietary name: Salicylic Acid
Dosage form: GEL
Route: TOPICAL
Labeler: Bioelements Inc.
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-05-05
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 2 mL/100mL
NDC exclude flag: E
Listing certified through: 2018-12-31
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	49825-113		I	Inactivated by FDA	2026-10-21
excluded package	package	49825-113	49825-113-02	I	Inactivated by FDA	2026-10-21
excluded package	package	49825-113	49825-113-04	I	Inactivated by FDA	2026-10-21

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	49825-113-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49825-113-02	`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	49825-113-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49825-113-02	`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	49825-113-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49825-113-02	`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	49825-113-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49825-113-02	`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	49825-113-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49825-113-02	`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	49825-113-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49825-113-02	`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	49825-113-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49825-113-02	`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	49825-113-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49825-113-02	`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	49825-113-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49825-113-02	`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	49825-113-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49825-113-02	`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	49825-113-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49825-113-02	`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	49825-113-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49825-113-02	`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	49825-113-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49825-113-02	`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	49825-113-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49825-113-02	`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	49825-113-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49825-113-02	`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	49825-113-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49825-113-04	`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	49825-113-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	49825-113-04	`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	49825-113-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	49825-113-04	`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	49825-113-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	49825-113-04	`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	49825-113-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	49825-113-04	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
49825-113-02	2020-01-31	C162847	48780-1	9d75b9d0-b152-f424-e053-dadaa90a57ce	Spotless Cleanser
49825-113-04	2020-01-31	C162847	48780-1	9d75b9d0-b152-f424-e053-dadaa90a57ce	Spotless Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49825-113-01	BioelementsSpotless Cleanser	88 mL in 1 BOTTLE	GEL	88	16
49825-113-02	BioelementsSpotless Cleanser	1 in 1 BOX	GEL	1	16
49825-113-03	BioelementsSpotless Cleanser	236 mL in 1 BOTTLE	GEL	236	16
49825-113-04	BioelementsSpotless Cleanser	1 in 1 BOX	GEL	1	16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
LAURYL GLUCOSIDE	INACTIVE INGREDIENT	76LN7P7UCU	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
PAPAYA	INACTIVE INGREDIENT	KU94FIY6JB	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
PINEAPPLE	INACTIVE INGREDIENT	2A88ZO081O	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49825-113	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16	Legacy NDC, 4 package rows	20120419_97d59626-8a37-4e9b-8074-0038b9626308.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O414PZ4LPZ	SALICYLIC ACID	69-72-7	SALICYLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
562600	salicylic acid 2 % Medicated Liquid Soap	PSN	97d59626-8a37-4e9b-8074-0038b9626308	16
562600	salicylic acid 20 MG/ML Medicated Liquid Soap	SCD	97d59626-8a37-4e9b-8074-0038b9626308	16
562600	salicylic acid 2 % Facial Cleanser Toner	SY	97d59626-8a37-4e9b-8074-0038b9626308	16
562600	salicylic acid 2 % Facial Scrub	SY	97d59626-8a37-4e9b-8074-0038b9626308	16
562600	salicylic acid 2 % Medicated Liquid Soap	SY	97d59626-8a37-4e9b-8074-0038b9626308	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
49825-113-01	49825011301	88 mL in 1 BOTTLE	88 ml	Historical
49825-113-02	49825011302	1 in 1 BOX		Historical
49825-113-03	49825011303	236 mL in 1 BOTTLE	236 ml	Historical
49825-113-04	49825011304	1 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spotless Cleanser	Bioelements Inc. \| United 1International \| Bell International Laboratories	2012-04-18	HUMAN OTC DRUG LABEL	16