Molecular AF

Product NDC: 76348-401
11-digit product format: 763480401
Labeler code: 76348
Product ID: 76348-401_2d3f2f5e-be56-71e9-e063-6294a90a6ac2
Type: HUMAN OTC DRUG
Nonproprietary name: tolnaftate
Dosage form: OIL
Route: TOPICAL
Labeler: Renu Laboratories, LLC
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-07-01
Substance: TOLNAFTATE
Active strength: .01 mg/mL
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 · 27 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
2025-02-02 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	76348-401-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76348-401-01	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	76348-401-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76348-401-01	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	76348-401-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76348-401-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76348-401-02	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76348-401-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76348-401-02	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76348-401-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76348-401-02	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76348-401-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76348-401-02	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76348-401-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76348-401-02	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76348-401-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	76348-401-02	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	76348-401-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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: Molecular AF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLNAFTATE	.01 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
06KB629TKV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1362937	Internal RxNorm lookup
1362942	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
1b47e687-29cf-48ce-8bc3-ac8f44f05baa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
76348-401-01	2025-02-04	MOLECULAR AF
76348-401-02	2025-02-04	MOLECULAR AF
76348-401-01	2025-01-30	MOLECULAR AF
76348-401-02	2025-01-30	MOLECULAR AF
76348-401-01	2023-06-13	MOLECULAR AF
76348-401-02	2023-06-13	MOLECULAR AF
76348-401-01	2020-01-31	MOLECULAR AF
76348-401-02	2020-01-31	MOLECULAR AF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-401-01	Molecular AF	11.5 mL in 1 BOTTLE	OIL	11.5		4
76348-401-02	Molecular AF	11.5 mL in 1 BOX	OIL	11.5		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]	2
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]	2
CINNAMON OIL	INACTIVE INGREDIENT	E5GY4I6YCZ	MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]	2
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]	2
ETHYL MACADAMIATE	INACTIVE INGREDIENT	ANA2NCS6V1	MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]	2
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]	2
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-401	MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20250206_1b47e687-29cf-48ce-8bc3-ac8f44f05baa.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 16 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nailtific Daytime Treatment Antifungal Pen Refill	NAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILL	Guangzhou Meixi Biotechnology Co., Ltd.	4257ee32-0d8f-08d4-e063-6294a90a4a89	2026-04-11	Warnings	Exact identifier application number: M005
Nailtific Nighttime Antifungal Renewal Pen Refill	TOLNAFTATE	Guangzhou Meixi Biotechnology Co., Ltd.	42634fc7-d0c7-4813-e063-6294a90a702d	2026-04-11	Warnings	Exact identifier application number: M005
Maximum Strength Antifungal Liquid	TOLNAFTATE	Chain Drug Marketing Association Inc	1a4f4d10-6782-ddb4-e063-6294a90ac206	2026-04-09	Warnings	Exact identifier application number: M005
Extra Strength Toenail Renewal Solution	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eed68e6-6814-0181-e063-6394a90a888e	2026-04-08	Warnings	Exact identifier application number: M005
TAGOQHIA Extra Strength NAIL REPAIR PEN	TOLNAFTATE, UNDECYLENIC ACID	Guangzhou Borderless Technology Co., Ltd.	4eefbef4-7643-dca4-e063-6394a90a72c1	2026-04-08	Warnings	Exact identifier application number: M005
ZYNTHIX	UNDECYLENIC ACID SOLUTION	Shenzhen Siwei Yijiu Trading Co., Ltd.	4ef4a167-f673-efb4-e063-6294a90a3026	2026-04-08	Warnings	Exact identifier application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL PEN	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eea5ee7-0ef9-8d34-e063-6294a90af595	2026-04-07	Warnings	Exact identifier application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL Solution	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eeaa2f0-efc7-eab3-e063-6294a90a13b3	2026-04-07	Warnings	Exact identifier application number: M005
Extra Strength Toenail Renewal Pen	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eeb59d2-3891-2e45-e063-6294a90a4fcf	2026-04-07	Warnings	Exact identifier application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.	CLOTRIMAZOLE 1%	RoyceDerm LLC	4e889f2b-9ea1-b1a6-e063-6394a90a4654	2026-04-03	Warnings	Exact identifier application number: M005
Dryello Tolnaftate 1% Antifungal	TOLNAFTATE	ProPedix, Inc.	4e962ca4-80ee-a379-e063-6394a90a1322	2026-04-03	Warnings	Exact identifier application number: M005
Toenail Fungus Treatment Extra Strength Pen	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	28fbcc50-a3ac-d6d1-e063-6294a90aa2b6	2026-04-02	Warnings	Exact identifier application number: M005
TOENAIL FUNGUS TREATMENT Liquid	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	28fc7049-e367-42bf-e063-6394a90a6f06	2026-04-02	Warnings	Exact identifier application number: M005
Fungal Nail Patches	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	299a63ad-f321-117c-e063-6394a90a3a22	2026-04-02	Warnings	Exact identifier application number: M005
Secura Antifungal Greaseless	MICONAZOLE NITRATE	Smith & Nephew Medical Ltd	9be600e4-76ec-4071-a8ec-a0b23155271d	2026-04-02	Warnings	Exact identifier application number: M005
FifthPulse Bacitracin Zinc	BACITRACIN ZINC	WeCare Products LLC	5c6b3ad8-c158-4cc0-b1ba-b829b5df1284	2026-04-02	Warnings	Exact identifier application number: M005
FifthPulse Miconazole Nitrate Antifungal	MICONAZOLE NITRATE	WeCare Products LLC	b70238eb-afcb-4e09-976f-973df249241c	2026-04-02	Warnings	Exact identifier application number: M005
ANTIFUNGAL PEN	UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE	Hanyang Qisheng (Shenzhen) Technology Co., Ltd.	4e85f338-ffd7-85b1-e063-6294a90a3c87	2026-04-02	Warnings	Exact identifier application number: M005
RoyceDerm Anti-Fungal Cream	MICONAZOLE NITRATE 2%	RoyceDerm LLC	4e861073-88e8-b2f7-e063-6394a90ab94a	2026-04-02	Warnings	Exact identifier application number: M005
Miconazole Nitrate	JOCK ITCH SPRAY	CVS Pharmacy	7b70d3ea-126a-42aa-8509-b982893c710b	2026-04-01	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
06KB629TKV	TOLNAFTATE	2398-96-1	TOLNAFTATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1362942	Molecular AF 1 % Antifungal Topical Oil	PSN	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	4
1362937	tolnaftate 1 % Topical Oil	PSN	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	4
1362942	tolnaftate 10 MG/ML Topical Oil [Molecular AF]	SBD	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	4
1362937	tolnaftate 10 MG/ML Topical Oil	SCD	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	4
1362942	Molecular AF 1 % Topical Oil	SY	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	4
1362942	Molecular AF 10 MG/ML Topical Oil	SY	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	4
1362937	tolnaftate 1 % Topical Oil	SY	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76348-401-01	76348040101	11.5 mL in 1 BOTTLE (76348-401-01)	11.5 ml	2011-07-01	No	No	Current
76348-401-02	76348040102	11.5 mL in 1 BOX (76348-401-02)	11.5 ml	2011-07-01	No	No	Current