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 9 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LQNZJBAU Nail Repair Pen	UNDECYLENIC ACID	Guangzhou Xinhongda Trading Service Co., Ltd.	55236084-42f4-6ada-e063-6394a90ac846	2026-06-26	Warnings	Exact identifier application number: M005
VORVITA Nail Hardener	PANTHENOL,HYALURONIC ACID	HK Vorvita Technology Co., Limited	51d5d3c7-ca25-3ee5-e063-6294a90a3a05	2026-06-26	Warnings	Exact identifier application number: M005
natouch	MICONAZOLE	Natouch LLC	55210a9d-6c47-4fc7-e063-6294a90a3653	2026-06-25	Warnings	Exact identifier application number: M005
YEARCHOICE Fungal Nail Repair Pen	FUNGAL NAIL REPAIR PEN	Guangzhou Jingliang Cosmetics Co., Ltd.	5500b582-0641-498d-e063-6394a90a3c58	2026-06-24	Warnings	Exact identifier application number: M005
FIobow FUNGAL NAIL TREATMENT	TOLNAFTATE 1% FUNGAL NAIL TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a49db2b-e45a-57c5-e063-6294a90a065c	2026-06-23	Warnings	Exact identifier application number: M005
RoyceDerm Antifungal .spray.	CLOTRIMAZOLE 1%	RoyceDerm LLC	54d3ae29-8919-4868-e063-6294a90a587e	2026-06-22	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT LIQUID	Walgreens Company	94f4f656-e8a3-4439-b53c-12be59dc8eac	2026-06-20	Warnings	Exact identifier application number: M005
VTROUY Fungal Nail Renewal Pen	FUNGAL NAIL RENEWAL PEN	Guangzhou Jingliang Cosmetics Co., Ltd.	549bf490-99c2-c800-e063-6394a90a672b	2026-06-19	Warnings	Exact identifier application number: M005
Terramed Just Think Comfort Armor Antifungal Body Wash Tea Tree	TOLNAFTATE	Rida LLC	0c7a3b2d-8b1c-4130-86ad-892a59157480	2026-06-19	Warnings	Exact identifier application number: M005
Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution	CLOTRIMAZOLE	Rida LLC	83a9c5dc-c969-43a7-a763-44783710d5d0	2026-06-18	Warnings	Exact identifier application number: M005
Anytalk FUNGAL NAIL TREATMENT	TOLNAFTATE 1%	Guangzhou Huixue Biotechnology Co., Ltd.	54718558-376f-ed31-e063-6294a90a5220	2026-06-17	Warnings	Exact identifier application number: M005
KLIPP FUNGAL NAIL TREATMENT	KLIPP FUNGAL NAIL TREATMENT	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	547f2fbe-a2de-057d-e063-6394a90ac742	2026-06-17	Warnings	Exact identifier application number: M005
GeriGentle Miconazole nitrate	ANTIFUNGAL	GERI-GENTLE CORPORATION	0ae03b4a-06c8-ddf9-e063-6294a90ad105	2026-06-16	Warnings	Exact identifier application number: M005
WKPIKI FUNGAL NAIL REPAIR PEN	UNDECYLENIC ACID 25% FUNGAL NAIL REPAIR PEN	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	54472c44-93de-d4b9-e063-6394a90adde1	2026-06-15	Warnings	Exact identifier application number: M005
BIOSHUGA Dermomucosal Antibacterial Gel	BIOSHUGA DERMOMUCOSAL ANTIBACTERIAL GEL	Guangxi Rise Biological Technology Co.,Ltd.	5456574a-dda4-9c67-e063-6294a90ac222	2026-06-15	Warnings	Exact identifier application number: M005
BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL Solution	BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SOLUTION	Guangxi Rise Biological Technology Co.,Ltd.	5457a623-7812-e516-e063-6394a90a8bfd	2026-06-15	Warnings	Exact identifier application number: M005
TOYKNIER MULTI-PURPOSE TREATMENT	UNDECYLENIC ACID 25% MULTI-PURPOSE TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4f8eb3a3-8f26-50dd-e063-6294a90ad9f8	2026-06-14	Warnings	Exact identifier application number: M005
CYYZROSE ANTIFUNGAL NAIL	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	527765d4-6988-ed4e-e063-6394a90a2f23	2026-06-14	Warnings	Exact identifier application number: M005
HEALMUSZ FUNGAL NAIL	TOLNAFTATE 1% FUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a2317d2-e45b-1fe2-e063-6394a90a940d	2026-06-14	Warnings	Exact identifier application number: M005
HEALMUSZ FUNGI NAIL	TOLNAFTATE 1% FUNGI NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a23c01b-492d-324b-e063-6394a90a73b1	2026-06-14	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