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 104 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Healing Hand Cream 2000mg	MENTHOL	Carolina Cannabis Creations LLC	01f8795b-9f95-c793-e063-6394a90a8330	2025-01-15	Warnings	Exact identifier application number: M017
CBD Clinic Deep-Rub Pain Relief - Level 5	CAMPHOR, MENTHOL	ABACUS HEALTH PRODUCTS, INC.	31e2e5cd-d33e-f058-e063-6394a90af7d2	2025-01-14	Warnings	Exact identifier application number: M017
Meijer Odor Free Analgesic Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	6288efea-f636-4eea-bb9f-78aa2f9af54a	2025-01-14	Warnings	Exact identifier application number: M017
IKONIK TONIK	LIDOCAINE HYDROCHLORIDE	IKONIK CARE, LLC	122fdfe8-b5fa-46d1-9fd9-3df9887ed320	2025-01-14	Warnings	Exact identifier application number: M017
elp essential MANTECA DE UBRE	METHYL SALICYLATE, CAMPHOR	Miramar Cosmetics, Inc DBA Miramar Lab	c3964dfe-17fe-4d89-a4c4-cf500f982259	2025-01-13	Warnings	Exact identifier application number: M017
Methylten	METHYL SALICYLATE 10%	Puretek Corporation	28f4093f-803f-0e70-e063-6294a90a98a4	2025-01-13	Warnings	Exact identifier application number: M017
Refill Bundle 7 Large Office	BENZALKONIUM CHLORIDE	CMC Group, Inc.	6620a8f3-098d-d045-e053-2a91aa0a0d94	2025-01-13	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2ba1de83-494a-6c54-e063-6294a90a9b2d	2025-01-13	Warnings	Exact identifier application number: M017
Arthritis Hot	MENTHOL AND METHYL SALICYLATE	Chattem, Inc.	cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd	2025-01-13	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b40dda-53ad-0458-e063-6394a90aa835	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b47eb7-6b43-d9e2-e063-6294a90a9a38	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 4% Lidocaine Fabric Tape	LIDOCAINE 4% FABRIC TAPE	Transfer Technology	e9a894b0-54f2-707e-e053-2a95a90a0f0d	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 3 in 1 Patch	MENTHOL, CAMPHOR, METHYL SALICYLATE PATCH	Transfer Technology	e9ab9a03-b9e3-7317-e053-2995a90a9950	2025-01-11	Warnings	Exact identifier application number: M017
ASTRAPHARM CHILLI BRAND	CAPSAICIN	Dersan Pharmaceutical Co., Ltd	b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec	2025-01-10	Warnings	Exact identifier application number: M017
LABOFLEX Lidocaine Pain Relieving Patch	LIDOCAINE 4%	Laboflex, Inc.	31995f31-c272-afdb-e063-6294a90af3f9	2025-01-10	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Chain Drug Marketing Association Inc.	2b48cb2f-e6bf-f9de-e063-6394a90a42d4	2025-01-09	Warnings	Exact identifier application number: M017
PAIN-X	MENTHOL	OL PHARMA TECH,LLC	b22bb19a-14e5-3d32-e053-2a95a90ae520	2025-01-09	Warnings	Exact identifier application number: M017
MUSCLE RUB	MENTHOL	OL PHARMA TECH,LLC	b22c7999-52d5-25c3-e053-2a95a90a01f5	2025-01-09	Warnings	Exact identifier application number: M017
Biofreeze Professional Colorless Roll-On	MENTHOL, UNSPECIFIED FORM	A-S Medication Solutions	ce392c4f-cc43-484d-9c49-18fa25e4e5e9	2025-01-09	Warnings	Exact identifier application number: M017
NEW TEROCIN	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	A-S Medication Solutions	43e5eb27-5541-4b7b-80de-55a79a4dce55	2025-01-09	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