PR

Product NDC: 72358-101
11-digit product format: 723580101
Labeler code: 72358
Product ID: 72358-101_4229f4ae-8934-0e10-e063-6394a90a4185
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: LOTION
Route: TOPICAL
Labeler: Amphp, Inc
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-11-01
Substance: MENTHOL
Active strength: .5 g/100g
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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72358-101-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72358-101-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72358-101-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72358-101-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72358-101-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72358-101-03	`0efc9e666f02…`	`f202fb6c5f17…`

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: PR
Listing expiration: 2026-12-31

Active Ingredients#

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

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
1293193	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
6f5b9e08-c445-4fac-e053-2a91aa0aa737	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
72358-101-03	2025-03-03	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-03	2025-03-03	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-04	2025-03-03	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-04	2025-03-03	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-03	2025-01-30	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-03	2025-01-30	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-04	2025-01-30	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-04	2025-01-30	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-01	2022-02-14	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-01	2022-02-14	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-02	2022-02-14	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-02	2022-02-14	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-03	2022-02-14	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-03	2022-02-14	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-01	2022-01-28	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-01	2022-01-28	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-02	2022-01-28	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-02	2022-01-28	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-03	2022-01-28	6f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-03	2022-01-28	6f5b9e08-c445-4fac-e053-2a91aa0aa737

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72358-101-03	PR	20 g in 1 PACKET	LOTION	20		9
72358-101-04	PR	300 g in 1 BOTTLE, PLASTIC	LOTION	300		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72358-101	PR (MENTHOL) LOTION [AMPHP, INC]	8	Current NDC, Legacy NDC, 2 package rows	20250305_6f5b9e08-c445-4fac-e053-2a91aa0aa737.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 17 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MyDerm Aloe and Lidocaine	LIDOCAINE	Medline Industries	fdfd4388-cd27-467b-959b-249a49ea5cf6	2026-05-26	Warnings	Exact identifier application number: M017
MyDerm Aloe and Lidocaine	LIDOCAINE	Inspec Solutions LLC.	4939c663-a876-4527-822a-df02964fa694	2026-05-26	Warnings	Exact identifier application number: M017
Lidocaine Menthol Pain Relief	LIDOCAINE, MENTHOL	Amerisource Bergen	94039190-dde3-4d8e-873a-79abd3f6208b	2026-05-26	Warnings	Exact identifier application number: M017
topcare hydrocortisone	HYDROCORTISONE	Topco Associates LLC	858053a0-d888-4bb9-b94e-503bcf3864cb	2026-05-21	Warnings	Exact identifier application number: M017
Arthritis Pain Relief Cream	HISTAMINE DIHYDROCHLORIDE	Sombra Cosmetics Inc.	523333ee-eccd-bcf7-e063-6394a90aea60	2026-05-21	Warnings	Exact identifier application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving Drops	MENTHOL	NEWMARKET HEALTH PRODUCTS, LLC	068343b8-0435-40d0-846c-9d8624e8b6c4	2026-05-21	Warnings	Exact identifier application number: M017
DO ME DELAY	LIDOCAINE HCL	Prodigy Media Inc	5255ee85-6f29-0776-e063-6394a90a525b	2026-05-21	Warnings	Exact identifier application number: M017
Australian Dream Back Pain	HISTAMINE DIHYDROCHLORIDE	Sombra Cosmetics Inc.	5256a63e-e6da-84c1-e063-6294a90a8dff	2026-05-21	Warnings	Exact identifier application number: M017
SINSIN HANBANG FLEX	CAMPHOR, MENTHOL	Sinsin Pharmaceutical co., ltd.	525c5d18-bfc1-3002-e063-6394a90a5b1d	2026-05-21	Warnings	Exact identifier application number: M017
LidoPro Patch	LIDOCAINE, MENTHOL, AND METHYL SALICYLATE	Preferred Pharmaceuticals Inc.	6c9a076e-6316-427b-9ce6-c8fe2d388837	2026-05-21	Warnings	Exact identifier application number: M017
Medi-First Capsaicin Cream	CAPSAICIN	Unifirst First Aid Corporation	49eb807b-fa31-3d84-e063-6394a90acfcf	2026-05-20	Warnings	Exact identifier application number: M017
Biofreeze Triple Target Roll-On	CAMPHOR, CAPSAICIN, MENTHOL	Reckitt Benckiser LLC	5089c088-3026-233a-e063-6394a90a93b6	2026-05-19	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Patch	LIDOCAINE	GERI-CARE PHARMACEUTICAL CORP	522f1521-f9f2-4c26-e063-6394a90a9e05	2026-05-19	Warnings	Exact identifier application number: M017
Easment 0.1% Capsaicin Roll on	CAPSAICIN 0.1%	Easment LLC	521212d6-57fd-4a7a-e063-6294a90a2a18	2026-05-18	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	WALMART INC.	15af4557-4baf-c177-e063-6294a90a7a5b	2026-05-18	Warnings	Exact identifier application number: M017
Blistex Maximum Hydration Lip	CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL	Blistex Inc.	fed223bc-edf3-46eb-b678-acb906f9ef11	2026-05-18	Warnings	Exact identifier application number: M017
Tiger Balm	CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	5066dc10-e4d5-49e9-9a5f-0ac220cfbf28	2026-05-18	Warnings	Exact identifier application number: M017
Deep Blue Mini	MENTHOL	doTERRA International, LLC	51dd58a8-1fd5-9cd7-e063-6394a90a1f72	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Overnight Gel	MENTHOL	Reckitt Benckiser LLC	f5c8c08b-c7c0-f84d-e053-2a95a90add15	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	00bba5d2-b0e0-701c-e063-6294a90a5741	2026-05-15	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1293193	menthol 0.5 % Topical Lotion	PSN	6f5b9e08-c445-4fac-e053-2a91aa0aa737	9
1293193	menthol 5 MG/ML Topical Lotion	SCD	6f5b9e08-c445-4fac-e053-2a91aa0aa737	9
1293193	menthol 0.5 % Topical Lotion	SY	6f5b9e08-c445-4fac-e053-2a91aa0aa737	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72358-101-01	72358010101	300 g in 1 TUBE (72358-101-01)	300 g	2018-11-01	0000-00-00	No	No	Current
72358-101-02	72358010102	100 g in 1 TUBE (72358-101-02)	100 g	2018-11-01	0000-00-00	No	No	Current
72358-101-03	72358010103	20 g in 1 PACKET (72358-101-03)	20 g	2018-11-01	0000-00-00	No	No	Current
72358-101-04	72358010104	300 g in 1 BOTTLE, PLASTIC (72358-101-04)	300 g	2018-11-01	0000-00-00	No	No	Current

PR