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 45 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hongo Killer	UNDECYLENIC ACID	Efficient Laboratories Inc	5c433182-0c0c-4a0a-8dd8-a14f60e52425	2024-10-14	Warnings	Exact identifier application number: M005
Miconazole nitrate	ANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAY	Meijer Distribution Inc	6c2ebe17-994d-41c8-bacb-87b6a63b2db4	2024-10-14	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTIFUNGAL	McKesson	8dcca44a-16c7-7262-e053-2a95a90a1b23	2024-10-10	Warnings	Exact identifier application number: M005
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	ebc565bb-e56c-43ba-a5cb-d2fad2aafc4a	2024-10-07	Warnings	Exact identifier application number: M005
Micotrin AL	TOLNAFTATE	PureTek Corporation	cc0fba1e-82c5-42fd-e053-2995a90af249	2024-10-02	Warnings	Exact identifier application number: M005
Mycozyl AL	TOLNAFTATE	PureTek Corporation	b82c9a8a-f6f1-dca6-e053-2995a90a47f9	2024-10-02	Warnings	Exact identifier application number: M005
MY MEDIC SUPER SANITIZER	ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	f19971b1-2aeb-4c37-82b0-9525026cff7a	2024-10-02	Warnings	Exact identifier application number: M005
Micotrin AC	CLOTRIMAZOLE	PureTek Corporation	cbe4dd18-c9ef-a4e4-e053-2995a90a5289	2024-10-01	Warnings	Exact identifier application number: M005
Micotrin AP	MICONAZOLE NITRATE	PureTek Corporation	cbe3d495-cdee-2343-e053-2a95a90a5b82	2024-10-01	Warnings	Exact identifier application number: M005
Mycozyl AC	CLOTRIMAZOLE	PureTek Corporation	b676d257-3cfd-7f24-e053-2995a90a546e	2024-10-01	Warnings	Exact identifier application number: M005
Mycozyl AP	MICONAZOLE NITRATE	PureTek Corporation	b3c46a30-7ff2-0dc4-e053-2995a90aa571	2024-10-01	Warnings	Exact identifier application number: M005
AOSI HEALTHCARE HAND SANITIZER	ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	59d631d0-d8ae-45a8-a7a9-26de9cc427b3	2024-09-25	Warnings	Exact identifier application number: M005
Clotrimazole 1%	CLOTRIMAZOLE	Dabur India Limited	22916978-303f-e62a-e063-6394a90a2100	2024-09-20	Warnings	Exact identifier application number: M005
Mentholatum Heel Revival Cream	MENTHOLATUM HEEL REVIVAL CREAM	The Mentholatum Company	21b643c2-eb6e-8939-e063-6394a90aaeac	2024-09-09	Warnings	Exact identifier application number: M005
VAGISTEN-V 7 DAY	MICONAZOLE NITRATE	OPMX LLC	a5bfa501-5ae1-4434-bc31-995d0665b99e	2024-09-04	Warnings	Exact identifier application number: M005
COTTON ON FOUNDATION Tropical Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	3645359c-06a2-4b97-b982-c54e4a0b8cda	2024-09-04	Warnings	Exact identifier application number: M005
COTTON ON FOUNDATION Coastal Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	645c09dc-15a4-481f-a605-f12fb8f8e9bd	2024-09-04	Warnings	Exact identifier application number: M005
Publix Athletic Foot	CLOTRIMAZOLE 1%	PUBLIX SUPER MARKETS, INC.	d9f99680-5636-4136-a7c6-c3643339e6b4	2024-08-02	Warnings	Exact identifier application number: M005
ANTIFUNGAL FOOT	TOLNAFTATE	Universal Distribution Center LLC	10579848-5793-4d72-ad5f-62d191c71074	2024-07-16	Warnings	Exact identifier application number: M005
MY MEDIC SUPER SANITIZER	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf3	2024-07-02	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