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 123 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZYLOTROL PAIN RELIEVING	LIDOCAINE HCL, MENTHOL	Asclemed USA, Inc.	1553351c-aee8-4c40-9548-35cce246bda9	2024-10-25	Warnings	Exact identifier application number: M017
Outgro	BENZOCAINE	Medtech Products Inc.	d6be8a1d-aca7-42b1-86da-881d42ffe8d5	2024-10-25	Warnings	Exact identifier application number: M017
Monistat Complete Care Instant Itch Relief	HYDROCORTISONE	Insight Pharmaceuticals LLC	a0f40504-6183-4f32-8d17-6586b3f386a6	2024-10-25	Warnings	Exact identifier application number: M017
Boil Ease	BENZOCAINE	Insight Pharmaceuticals LLC	bf108934-5e1a-4059-9dcf-008f52a83fab	2024-10-25	Warnings	Exact identifier application number: M017
Dermarest Eczema Medicated	HYDROCORTISONE	Insight Pharmaceuticals LLC	0292ab62-5088-45fa-a056-70c2fcc19ef7	2024-10-25	Warnings	Exact identifier application number: M017
anti itch	HYDROCORTISONE	Meijer, Inc.	2db7bcab-acb8-48ad-8cd1-842ff7765ed9	2024-10-23	Warnings	Exact identifier application number: M017
NATUREANCE MIRACLE	MENTHOL	EROS GLOBAL CORP	ec1a2a1f-a38d-9c59-e053-2a95a90ad268	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Plantar Relief Strips	CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	65e142d8-da21-4c55-9faf-b387cb6c2c0e	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	cc011b79-2761-40f7-8142-88f8e30a179a	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Profoot, Inc.	06f82bde-41a1-35f6-e063-6394a90a6437	2024-10-23	Warnings	Exact identifier application number: M017
Deep Cover Bug Bite Relief	BENZOCAINE	Morrisons Outdoors, LLC	25010dd6-fb48-8ee7-e063-6394a90aee6c	2024-10-21	Warnings	Exact identifier application number: M017
Evel Knievels Natural Choice Pain Relief	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	4576656c-4b6e-6965-7665-6c52756c6573	2024-10-21	Warnings	Exact identifier application number: M017
berkley and jensen anti itch	HYDROCORTISONE	BJWC	5cc6e4f6-c62d-4923-9726-9dbc569a3f49	2024-10-19	Warnings	Exact identifier application number: M017
DG Health Hydrocortisone Maximum Strength	HYDROCORTISONE	Dolgencorp Inc	2cc792b8-dce6-4178-bd6d-63ba268b7747	2024-10-19	Warnings	Exact identifier application number: M017
Careland Hydrogel Pain Relief Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	e970070c-1c3b-49f0-8298-e6c5ebbf50a0	2024-10-18	Warnings	Exact identifier application number: M017
Fruit of the Earth Cool Blue Aloe Mist Continuous	LIDOCAINE HYDROCHLORIDE	Fruit Of The Earth, Inc.	d4caae4c-efba-2453-e053-2995a90a5e5f	2024-10-18	Warnings	Exact identifier application number: M017
CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving	LIDOCAINE HCL	CVS Pharmacy	f0f1969d-10e0-76ee-e053-2995a90a7336	2024-10-17	Warnings	Exact identifier application number: M017
Wong To Yick External Analgesic	CAMPHOR MENTHOL METHYL SALICYLATE	Wong To Yick Wood Lock Ointment Ltd	16a21af4-6bc0-4ae1-aa3b-1da84c8286e2	2024-10-17	Warnings	Exact identifier application number: M017
Wong To Yick External Analgesic	CAMPHOR MENTHOL METHYL SALICYLATE	Wicsun Trading Inc	0b4bd444-b3c1-47aa-a7e3-f16c92326124	2024-10-17	Warnings	Exact identifier application number: M017
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL	LIDOCAINE	Fruit of the Earth, Inc.	c7a833bd-7457-73a3-e053-2a95a90ac53f	2024-10-17	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