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 13 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SSPROTIP X Extra Strength Nail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52512e7e-5e28-4383-e063-6294a90a448a	2026-05-21	Warnings	Exact identifier application number: M005
Vrenmol Extra Strength Nail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52516861-e386-d0cb-e063-6394a90a17d0	2026-05-21	Warnings	Exact identifier application number: M005
SSPROTIP X Extra Strength Toenail Renewal Solution	TOLNAFTATE,UNDECYLENIC ACID	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52519110-a3c9-21da-e063-6294a90abbce	2026-05-21	Warnings	Exact identifier application number: M005
NERANTE Antifungal Cream	MICONAZOLE NITRATE, HYDROCORTISONE	Guangzhou Xinhongda Trading Service Co., Ltd.	52281e10-59db-1d1c-e063-6394a90aadfe	2026-05-21	Warnings	Exact identifier application number: M005
Fungal Nail Repair Pen	UNDECYLENIC ACID	Yunqi Cosmetics (Shenzhen) Co., Ltd	523c32f7-b803-bf79-e063-6394a90aad5a	2026-05-20	Warnings	Exact identifier application number: M005
Medi-First Clotrimazole 1% ANTIFUNGAL Cream	CLOTRIMAZOLE	Unifirst First Aid Corporation	522eeb91-8378-32f4-e063-6394a90aff43	2026-05-20	Warnings	Exact identifier application number: M005
Kopa Haiku Antifungal Cream	MICONAZOLE NITRATE 2%	Trovina Co. Ltd	47cf1251-5965-045a-e063-6394a90ab04f	2026-05-19	Warnings	Exact identifier application number: M005
APUREE PRO Nailtific Maximum Strength Antifungal Patches	APUREE PRO NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES	Guangzhou Meixi Biotechnology Co., Ltd.	5218bd5d-53b4-107f-e063-6394a90ae769	2026-05-18		Exact identifier application number: M005
APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen	APUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN	Guangzhou Meixi Biotechnology Co., Ltd.	521a0e40-a218-fabb-e063-6294a90ae9a2	2026-05-18	Warnings	Exact identifier application number: M005
Beukow Antifungal Pen	UNDECYLENIC ACID 25% ANTIFUNGAL PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	511d1edf-dfda-477c-e063-6294a90aa423	2026-05-17	Warnings	Exact identifier application number: M005
Nail Repair Pen	NAIL REPAIR PEN	Shenzhen Earth Surface Trading Co., Ltd.	520f6514-6660-d6a8-e063-6394a90adf82	2026-05-17	Warnings	Exact identifier application number: M005
Fungicure Intensive	CLOTRIMAZOLE	Kobayashi Healthcare International, Inc.	1f1b413f-278e-434f-8590-4cf731663f5c	2026-05-15	Warnings	Exact identifier application number: M005
Dr Scholls Fungal Nail Clear and Cure Tolnaftate Antifungal	TOLNAFTATE	Scholl's Wellness Company LLC	8abd6d8e-c69e-4374-ace8-d42b2d3e171e	2026-05-14	Warnings	Exact identifier application number: M005
Dr.Scholl s Odor X Athlete s Foot	TOLNAFTATE	Scholl's Wellness Company LLC	0e864882-5e00-491e-a008-0762c131637a	2026-05-14	Warnings	Exact identifier application number: M005
Athletes Foot	TOLNAFTATE	Rugby Laboratories	50c46cf5-3e64-9e0f-e063-6294a90a2317	2026-05-14	Warnings	Exact identifier application number: M005
TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes	TOSSOYA RAINFOREST SECRETGUARD ANTIBACTERIAL QUICK-CLEANSE WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	3d53463d-8d8e-9030-e063-6294a90ab454	2026-05-13	Warnings	Exact identifier application number: M005
Anti-Fungal Powder	MICONAZOLE NITRATE	CVS Pharmacy	1651bdd7-ab15-7a2d-e063-6294a90a8b91	2026-05-11	Warnings	Exact identifier application number: M005
Lightning X Hand Cleanser	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	51861f1e-8961-e876-e063-6394a90a2fd0	2026-05-11	Warnings	Exact identifier application number: M005
APUREE Nailtific Maximum Strength Antifungal Patches PRO	APUREE NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES PRO	Guangzhou Meixi Biotechnology Co., Ltd	5189ebc5-8ee5-1b2c-e063-6294a90af5c8	2026-05-11	Warnings	Exact identifier application number: M005
APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen Pro	APUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PRO	Guangzhou Meixi Biotechnology Co., Ltd.	518abf2b-6ac8-ab9b-e063-6294a90ae693	2026-05-11	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