GlyCylic

Product NDC: 49406-009
11-digit product format: 494060009
Labeler code: 49406
Product ID: 49406-009_5e868b84-9e37-f72d-e063-6394a90a2381
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: 2027-12-31
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: 2027-12-31

Active Ingredients#

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

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 49 of 49 · 967 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	78131b57-1ffc-4eb8-821e-f7bb73300fe9	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	eb30e5de-9074-4760-8e92-e1d1c127227d	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	0bd3de76-b726-41f1-87bc-14ab8a1eca8e	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Prep Pad	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	be85ec5b-eb49-4f1a-a87d-5c9705a20f23	2023-10-22	Warnings	Exact identifier application number: M005
EVERLIT CARE Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	579c1ab5-50b4-4b5a-a189-c1e2827d0c3a	2023-10-14	Warnings	Exact identifier application number: M005
Micomitin Antifungal	CLOTRIMAZOLE	PureTek Corporation	dd05f5f9-2412-1295-e053-2995a90acb96	2022-02-14	Warnings	Exact identifier application number: M005
Micatin	MICONAZOLE NITRATE	WellSpring Pharmaceutical Corporation	96c56ba1-c3a8-48ce-ab58-550959485e3c	2016-04-07	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