GlyCylic

Product NDC: 49406-009
11-digit product format: 494060009
Labeler code: 49406
Product ID: 49406-009_3ca9f427-1896-790a-e063-6394a90a980a
Type: HUMAN OTC DRUG
Nonproprietary name: Salicylic Acid
Dosage form: LIQUID
Route: TOPICAL
Labeler: The Tetra Corporation
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-07-01
Substance: SALICYLIC ACID
Active strength: 17 g/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49406-009-15	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49406-009-15	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49406-009-15	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49406-009-15	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49406-009-15	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49406-009-15	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49406-009-15	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: GlyCylic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SALICYLIC ACID	17 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O414PZ4LPZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312880	Internal RxNorm lookup
2604784	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
501d3ba9-ba42-4c1c-983b-492adaee039d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49406-009-15	2025-08-18	C162847	48780-1	2cef2736-6ea4-d83d-e063-dadaa90ab31f	501d3ba9-ba42-4c1c-983b-492adaee039d
49406-009-15	2025-01-30	C162847	48780-1	2cef2736-6ea4-d83d-e063-dadaa90ab31f	501d3ba9-ba42-4c1c-983b-492adaee039d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49406-009-15	GlyCylic	1 in 1 BOX	LIQUID	1		5
49406-009-15	GlyCylic	15 mL in 1 BOTTLE	LIQUID	15		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49406-009	GLYCYLIC (SALICYLIC ACID) LIQUID [THE TETRA CORPORATION]	2	Current NDC, Legacy NDC, 2 package rows	20231013_501d3ba9-ba42-4c1c-983b-492adaee039d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 33 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FUNGAL NAILS REPAIRING ESSENCE	PEPPERMINT OIL	Zhenping Renren Industry Co., Ltd.	3e82649c-d784-d64c-e063-6294a90ac95d	2025-09-11	Warnings	Exact identifier application number: M005
equate Athletes Foot	TOLNAFTATE	Wal-Mart Stores Inc	e90297d0-0f87-4ae3-b9b7-959266d57c24	2025-09-11	Warnings	Exact identifier application number: M005
Bee Venom Toenail Fungus Treatment	BEE VENOM TOENAIL FUNGUS TREATMENT	Shenzhen Earth Surface Trading Co., Ltd.	3e7d22b0-2f57-fcac-e063-6394a90aefd9	2025-09-10	Warnings	Exact identifier application number: M005
Amerfresh Antibacterial Deodorant	BENZETHONIUM CHLORIDE	Liufangjing Biotechnology (Yangzhou) Co., Ltd	cdc4f0ff-07bd-47c8-850b-1698308bb660	2025-09-09	Warnings	Exact identifier application number: M005
Antifungal Cream	MICONAZOLE NITRATE	Encube Ethicals, Inc.	8be4bbfa-424c-4ccf-b8bc-65b16c126053	2025-09-04	Warnings	Exact identifier application number: M005
ANTIFUNGAL	CLOTRIMAZOLE	Encube Ethicals, Inc.	afbc28f8-bb76-424d-9d73-136e6c283ead	2025-09-04	Warnings	Exact identifier application number: M005
Hermon Balanitis relief kit	SULFUR 1X HPUS	Beautivity LLC	3dce086e-a4eb-4b21-e063-6394a90aa1b2	2025-09-02	Warnings	Exact identifier application number: M005
Extra Strength Nail Fungus Treatment	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3abc0892-e52b-a40f-e063-6294a90a0e35	2025-09-02	Warnings	Exact identifier application number: M005
Hermon Balanitis Cream	SULFUR 1X HPUS	Beautivity LLC	3dba4e4b-8224-6a96-e063-6394a90a9129	2025-09-01	Warnings	Exact identifier application number: M005
Caseys	BENZALKONIUM CHLORIDE	Zhejiang Bright Care Co., Ltd.	a29d6c19-01aa-45b0-92cd-3f1148bad4f8	2025-08-30	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE	VALU MERCHANDISERS, CO.	1d258684-9034-460c-953d-78e2b5198167	2025-08-26	Warnings	Exact identifier application number: M005
Femmesil Maximum Strength	MICONAZOLE NITRATE	Aidance Skincare & Topical Solutions, LLC	d8b01fe1-4465-497b-909e-f51f31fdf833	2025-08-25	Warnings	Exact identifier application number: M005
femmesil Ultra Therapy	CLOTRIMAZOLE	Aidance Scientific, Inc.	3d36794a-07d0-860c-e063-6294a90a6e8f	2025-08-25	Warnings	Exact identifier application number: M005
Nedtol Folliculitis Treatment Creams	MICONAZOLE NITRATE	Jiashen International Trade Limited	3d0a1e39-82e4-9337-e063-6294a90aa9a3	2025-08-23	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	TRIFECTA PHARMACEUTICALS USA LLC	6b74d405-42d6-4c46-ba78-3007d1e8ffb8	2025-08-23	Warnings	Exact identifier application number: M005
FUNGLARA Anti Fungal	UNDECYLENIC ACID	FUNGLARA LLC	a23c2399-36ea-4f22-8140-066e22c9a862	2025-08-20	Warnings	Exact identifier application number: M005
Rapid MicroGel	TOLNAFTATE	The Tetra Corporation	afb6d7c4-1f75-4694-83c8-d6469250d6a1	2025-08-19	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	AvPAK	3ca3b475-7b69-442a-e063-6294a90a7b3f	2025-08-18	Warnings	Exact identifier application number: M005
Formula 3	TOLNAFTATE	The Tetra Corporation	0895274b-a09d-4264-a43f-852e44eb3163	2025-08-18	Warnings	Exact identifier application number: M005
Formula 7 - The Solution	TOLNAFTATE	The Tetra Corporation	18619649-7f79-4b6e-8b7c-69d70365d557	2025-08-18	Warnings	Exact identifier application number: M005

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
2604784	GlyCylic 17 % Topical Gel	PSN	501d3ba9-ba42-4c1c-983b-492adaee039d	5
312880	salicylic acid 17 % Topical Gel	PSN	501d3ba9-ba42-4c1c-983b-492adaee039d	5
2604784	salicylic acid 0.17 MG/MG Topical Gel [Glycylic]	SBD	501d3ba9-ba42-4c1c-983b-492adaee039d	5
312880	salicylic acid 0.17 MG/MG Topical Gel	SCD	501d3ba9-ba42-4c1c-983b-492adaee039d	5
2604784	Glycylic 17 % Topical Gel	SY	501d3ba9-ba42-4c1c-983b-492adaee039d	5
312880	salicylic acid 17 % Topical Gel	SY	501d3ba9-ba42-4c1c-983b-492adaee039d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49406-009-15	49406000915	1 BOTTLE in 1 BOX (49406-009-15) / 15 mL in 1 BOTTLE	1 bottle	2022-07-01	0000-00-00	No	No	Current