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 10 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF	BENZALKONIUM CHLORIDE, LIDOCAINE	Enviro Specialty Chemicals Inc	f7abe66c-dc2d-4ef7-9b11-5b87157fd302	2026-07-21	Warnings	Exact identifier application number: M017
Bclsks NUMBING	MENTHOL 1% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	49e26770-ddf6-7515-e063-6394a90a4ab3	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE21MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5e9691-727f-6bcd-e063-6294a90aadfc	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE14MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5eec19-7f9a-d277-e063-6294a90ace95	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE7MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5f124e-2dd7-16b8-e063-6294a90a5cdb	2026-07-21	Warnings	Exact identifier application number: M017
Gaayou Numbing	DIBUCAINE HYDROCHLORIDE 0.5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4c290118-7880-2a98-e063-6294a90a4c03	2026-07-21	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving Cold Gel	CAMPHOR, MENTHOL	Active and Innovative	572792bb-2819-36c3-e063-6394a90aa504	2026-07-21	Warnings	Exact identifier application number: M017
SYLVIRENE NUMBING	LIDOCAINE 4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a36edc5-5a89-afb5-e063-6294a90a02dd	2026-07-21	Warnings	Exact identifier application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN	LIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN	Jiangxi Yudexi Pharmaceutical Co., LTD	4a45c1cb-c5ab-d872-e063-6394a90aab5d	2026-07-21	Warnings	Exact identifier application number: M017
SERYNTH Muscle Comfort	ARNICA MONTANA HPUS 7% MUSCLE COMFORT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c10cd-f0c4-8731-e063-6394a90a10a5	2026-07-21	Warnings	Exact identifier application number: M017
DERMFREE MEDICATED LIP	CAMPHOR 2.0% MEDICATED LIP	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d62fb-8dfa-404a-e063-6294a90a385d	2026-07-21	Warnings	Exact identifier application number: M017
NATUHEAL RELIEF Cream FOR ECZEMA	HYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMA	Jiangxi Yudexi Pharmaceutical Co., LTD	4c92fed1-a8b4-bda8-e063-6394a90a8a33	2026-07-20	Warnings	Exact identifier application number: M017
REDCOOL Arnica Bruise	ARNICA MONTANA HPUS 7% ARNICA BRUISE	Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.	49911392-e55e-1a6b-e063-6394a90a9af0	2026-07-20	Warnings	Exact identifier application number: M017
Vamy HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	499197aa-f872-3abf-e063-6294a90aeda2	2026-07-20	Warnings	Exact identifier application number: M017
Subleef NUMBING	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a201a6b-adde-c0a8-e063-6394a90a8285	2026-07-20	Warnings	Exact identifier application number: M017
PUVIDA NUMBING	MENTHOL 5% (W/W) NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4de4e317-2f4f-e5d6-e063-6394a90a0611	2026-07-20	Warnings	Exact identifier application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	8b607c03-a98f-445a-a69e-7625a76ac44b	2026-07-20	Warnings	Exact identifier application number: M017
Yodo Salil	OINTMENT	Laboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.	56812625-7eab-6a25-e063-6294a90a23fe	2026-07-20	Warnings	Exact identifier application number: M017
VBBV Numbing	LIDOCAINE	Jiashen International Trade Limited	5716c36b-6e97-c294-e063-6394a90aaf5c	2026-07-20	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	Premier Brands of America Inc.	560c29cc-2453-5d14-e063-6394a90a844f	2026-07-17	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