NOVUM

Product NDC: 69574-005
11-digit product format: 695740005
Labeler code: 69574
Product ID: 69574-005_32322747-0600-c81a-e063-6394a90ac71e
Type: HUMAN OTC DRUG
Nonproprietary name: menthol
Dosage form: SPRAY
Route: TOPICAL
Labeler: NOVUM SOLUTIONS INC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-05-19
Substance: MENTHOL
Active strength: .5 g/100mL
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 · 16 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	69574-005-05	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	69574-005-05	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	69574-005-05	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	69574-005-05	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	69574-005-05	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	69574-005-05	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	69574-005-05	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69574-005-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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: NOVUM
Brand name suffix: APR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1314935	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
1b869a1f-5787-4d03-a546-43a8217b2b2c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-04-07	1b869a1f-5787-4d03-a546-43a8217b2b2c
2025-01-30	1b869a1f-5787-4d03-a546-43a8217b2b2c
2023-11-03	1b869a1f-5787-4d03-a546-43a8217b2b2c
2023-01-30	1b869a1f-5787-4d03-a546-43a8217b2b2c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69574-005-04	NOVUMAPR	118.3 mL in 1 BOTTLE, SPRAY	SPRAY	118.3		7
69574-005-05	NOVUMAPR	1 in 1 BOX	SPRAY	1		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]	3
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]	3
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]	3
SPEARMINT OIL	INACTIVE INGREDIENT	C3M81465G5	NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69574-005	NOVUM APR (MENTHOL) SPRAY [NOVUM SOLUTIONS INC]	7	Current NDC, Legacy NDC, 2 package rows	20250409_1b869a1f-5787-4d03-a546-43a8217b2b2c.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 144 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IceQuake Analgestic White	METHYL SALICYLATE, MENTHOL	Southern Sales & Service, Inc.	54e5dcd5-9987-488d-a758-d0e76d155182	2023-11-29	Warnings	Exact identifier application number: M017
Icequake Coldn Hot medicated patch	MENTHOL	Southern Sales & Service, Inc.	89202c52-9eb7-4e5a-a709-4a66ab0d3a72	2023-11-29	Warnings	Exact identifier application number: M017
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	Southern Sales & Service, Inc.	9089cb78-e9f8-4437-a767-df809a114c4b	2023-11-29	Warnings	Exact identifier application number: M017
Ice Quake Muscle Rub Blue	MENTHOL	Southern Sales & Service, Inc.	5180f6a3-58f1-4c50-a33b-7d85a3c1b99b	2023-11-29	Warnings	Exact identifier application number: M017
Discount Drug Mart Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Discount Drug Mart	8579df23-ac07-9df8-e053-2991aa0a8bbb	2023-11-29	Warnings	Exact identifier application number: M017
Satohap	METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL	Sato Pharmaceutical Co., Ltd.	3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf	2023-11-28	Warnings	Exact identifier application number: M017
Poli-A	HYDROCORTISONE ACETATE	Sato Pharmaceutical Co., Ltd.	e27a3840-d9de-4bd0-ad75-8a151bd12b83	2023-11-28	Warnings	Exact identifier application number: M017
Sheffield Arthritis and Muscle Pain Relief	CAPSICUM OLEORESIN	Sheffield Pharmaceuticals LLC	724b9870-e86a-4087-ba78-8c944ce3baa6	2023-11-28	Warnings	Exact identifier application number: M017
Dr Sheffield Muscle Rub Cream	MUSCLE RUB CREAM	Sheffield Pharmaceuticals LLC	60d1d826-a53e-42e5-bc30-1b2c2690445b	2023-11-28	Warnings	Exact identifier application number: M017
Thera Plus Cold Therapy Pain Relieving Menthol	MENTHOL	Fourstar Group USA, Inc.	0a462c91-5300-e282-e063-6394a90a4cc2	2023-11-27	Warnings	Exact identifier application number: M017
UtaSpray	MENTHOL AND METHYL SALICYLATE	Big 5 Nutrition LLC	c641ab11-cd00-4e23-ace7-8178739084f0	2023-11-21	Warnings	Exact identifier application number: M017
Top Medicated Oil	CAMPHOR, MENTHOL, METHYL SALICYLATE	Big 5 Nutrition LLC	b2f0d1e1-7d03-434e-be39-9f980459690c	2023-11-21	Warnings	Exact identifier application number: M017
BT Pain Relief Balm	METHYL SALICYLATE, MENTHOL, CAMPHOR	Big 5 Nutrition LLC	50112419-c934-4d3a-9ea6-9b089f516a6d	2023-11-21	Warnings	Exact identifier application number: M017
BT Pain Relief	MENTHOL, METHYL SALICYLATE	Big 5 Nutrition LLC	91324910-27cf-424f-9e9b-6173f2d7acbf	2023-11-21	Warnings	Exact identifier application number: M017
Dit Da Shui	MENTHOL AND METHYL SALICYLATE	Big 5 Nutrition LLC	5d45cb48-3e88-4d58-81d2-6f88d7a82134	2023-11-20	Warnings	Exact identifier application number: M017
Herbal Balm	METHYL SALICYLATE, MENTHOL AND	Big 5 Nutrition LLC	09b3b86d-3434-428b-b0a8-e8dfd7c0b52a	2023-11-20	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	b505769e-9c46-3cf3-e053-2a95a90a4df9	2023-11-17	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	d6523993-d781-cdbc-e053-2a95a90af191	2023-11-17	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	4d91baf3-9655-4786-93b8-aa0d93fe0bf9	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMP	MENTHOL	KOBAYASHI Healthcare International, Inc.	7ef03298-6623-4cf4-b21f-74b2ffc11c6e	2023-11-16	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1314935	menthol 0.5 % Topical Spray	PSN	1b869a1f-5787-4d03-a546-43a8217b2b2c	7
1314935	menthol 5 MG/ML Topical Spray	SCD	1b869a1f-5787-4d03-a546-43a8217b2b2c	7
1314935	menthol 0.5 % Topical Spray	SY	1b869a1f-5787-4d03-a546-43a8217b2b2c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69574-005-04	69574000504	118.3 mL in 1 BOTTLE, SPRAY	118.3 ml					Historical
69574-005-05	69574000505	1 BOTTLE, SPRAY in 1 BOX (69574-005-05) / 118.3 mL in 1 BOTTLE, SPRAY (69574-005-04)		2015-05-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NOVUM APR - NOVUM SOLUTIONS INC \| Bio-Medical & Pharmaceutical Manufacturing Corporation	NOVUM SOLUTIONS INC \| Bio-Medical & Pharmaceutical Manufacturing Corporation	2025-04-07	HUMAN OTC DRUG LABEL	7