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 93 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VBBV Tattoo Numbing	LIDOCAINE	Jiashen International Trade Limited	3557859e-f8b3-1049-e063-6394a90ad737	2025-05-17	Warnings	Exact identifier application number: M017
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	35415851-beba-5bb4-e063-6294a90a35c0	2025-05-16	Warnings	Exact identifier application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	352798e1-1e09-3d47-e063-6394a90ad404	2025-05-15	Warnings	Exact identifier application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	35285d62-c660-a056-e063-6294a90aabc8	2025-05-15	Warnings	Exact identifier application number: M017
SionBiotext Hydrocortisone	HYDROCORTISONE ACETATE 1%	Sion Biotext Medical Ltd	35073eae-26fe-2bb5-e063-6294a90ab56a	2025-05-13	Warnings	Exact identifier application number: M017
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	3508ae14-d9c9-3c85-e063-6294a90a0098	2025-05-13	Warnings	Exact identifier application number: M017
SORE NO MORE WARM THERAPY	MENTHOL AND CAMPHOR	SOMBRA COSMETICS INC.	cd86b56e-9b4c-4aca-9740-c8793cb12055	2025-05-12	Warnings	Exact identifier application number: M017
SORE NO MORE COOL THERAPY	MENTHOL	SOMBRA COSMETICS INC.	9aa1f0ac-3baf-4e45-9e3a-c28a99b22909	2025-05-12	Warnings	Exact identifier application number: M017
Calm and Correct Serum with Lidocaine	LIDOCAINE 3 PERCENT	Renu Laboratories, LLC	ddcf1c2e-2f67-44d7-e053-2a95a90a812b	2025-05-09	Warnings	Exact identifier application number: M017
Mqupin Knee Patch	KNEE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	09772e4b-8193-3771-e063-6394a90a9516	2025-05-08	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	d57a59fb-c8f2-f73b-e053-2995a90a4cdb	2025-05-08	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	4c96ec41-841c-322b-e054-00144ff8d46c	2025-05-08	Warnings	Exact identifier application number: M017
GNP Extra Strength Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Amerisource Bergen	34a66224-ef3c-e36e-e063-6394a90ac99d	2025-05-08	Warnings	Exact identifier application number: M017
Good Neighbor Muscle Rub Cream	CAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%,	Amerisource Bergen	34924bb9-e3e8-70e6-e063-6294a90aaa8c	2025-05-07	Warnings	Exact identifier application number: M017
DermaRad Relief Post Radiation Calming	LIDOCAINE 3 PERCENT	Renu Laboratories, LLC	e5d64929-fb9c-7ebc-e053-2995a90a9318	2025-05-07	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	InterMed Laboratories Private Limited	33ee0235-5a6e-0ea1-e063-6394a90a89a5	2025-05-06	Warnings	Exact identifier application number: M017
DermaRad Relief	LIDOCAINE EMULSION	RENU LABORATORIES, LLC	d5e11f73-918b-eeac-e053-2995a90a4a83	2025-05-06	Warnings	Exact identifier application number: M017
Plantar Fasciitis Pain Relief Gel-Patch	LIDOCAINE, MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	34838622-b092-afeb-e063-6294a90ae7db	2025-05-06	Warnings	Exact identifier application number: M017
Climax Shield Delay	BENZOCAINE	PRODUCT MAX GROUP INC	9c720cdc-f753-47ce-95ff-3b26e461a0ab	2025-05-05	Warnings	Exact identifier application number: M017
PediFix Lidocaine Pain-Relief Patches	LIDOCAINE PAIN-RELIEF PATCHES	PediFix, Inc	346550b9-d2ba-184e-e063-6394a90a591a	2025-05-05	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