SMOOTH GATOR Head-Ezz Analgesic

Product NDC: 70673-501
11-digit product format: 706730501
Labeler code: 70673
Product ID: 70673-501_1a820f59-518c-a238-e063-6294a90a1d1f
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: CREAM
Route: TOPICAL
Labeler: Smooth Gator LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-06-13
Substance: MENTHOL
Active strength: 30 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: SMOOTH GATOR Head-Ezz Analgesic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	30 mg/mL

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
1442261	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
02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70673-501-00	SMOOTH GATOR Head-Ezz Analgesic	60 mL in 1 BOTTLE	CREAM	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70673-501	SMOOTH GATOR HEAD-EZZ ANALGESIC (MENTHOL) CREAM [SMOOTH GATOR LLC]	1	Current NDC, 1 package rows	20240613_02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd.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 132 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	0e808f89-62dc-3790-e063-6394a90a2351	2024-05-13	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Plus Cream	BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE	Walgreens Company	e33e0097-31d6-8083-e053-2a95a90af5d2	2024-05-09	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold Gel	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1794c512-5f42-4ec3-e063-6394a90a87cd	2024-05-03	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro	MENTHOL AND CAMPHOR	ACTIVE AND INNOVATIVE, LLC	17961a84-6bee-c75f-e063-6394a90af576	2024-05-03	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Pain Relieving Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd	2024-05-01	Warnings	Exact identifier application number: M017
Lidocaine HCl 4 Percent	LIDOCAINE HYDROCHLORIDE	ARI BRANDS, LLC	81aff5c5-91c0-4173-a432-d20115613580	2024-04-30	Warnings	Exact identifier application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 Bulk	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	17545078-05e1-9338-e063-6394a90a678c	2024-04-30	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Roll-on	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1755ec89-c404-1c17-e063-6394a90ab9fb	2024-04-30	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Roll On	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bc2a14-6bda-428c-e053-2995a90a4ced	2024-04-29	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Tube	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bec1d4-2e18-4519-e053-2a95a90a1bbb	2024-04-29	Warnings	Exact identifier application number: M017
THERAPLEX AIM Anti-Itch Moisturizing	HYDROCORTISONE	THERAPLEX, LLC	d1b231b6-cc9f-488a-9121-501831473772	2024-04-27	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE ACETATE	JHK Inc dba American Safety & First Aid	64adc8d0-7ca4-4c1a-813f-f1df47e916f2	2024-04-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Plus Cream	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	16f26249-b508-2c6e-e063-6394a90a265b	2024-04-25	Warnings	Exact identifier application number: M017
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Cardinal Health 110 dba LEADER	16f2f3cb-4611-5867-e063-6394a90af107	2024-04-25	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	JHK Inc	5a4ac4cc-015a-48e7-81f8-93a895049afd	2024-04-25	Warnings	Exact identifier application number: M017
Cold Therapy Pain Relief	MENTHOL, UNSPECIFIED FORM	Walgreen Co.	ede15818-5d17-477d-a8be-7b36bb0770a6	2024-04-22	Warnings	Exact identifier application number: M017
Anti Itch	HYDROCORTISONE	Neilmed Pharmaceuticals Inc.	14b4f066-fde4-ac97-e063-6394a90ae64c	2024-04-20	Warnings	Exact identifier application number: M017
Walgreens Cold Therapy Pain Relief Patch	MENTHOL 5%	Walgreens Company	e33c90d1-2729-970f-e053-2995a90ad97a	2024-04-18	Warnings	Exact identifier application number: M017
HealthWise Cold Therapy Pain Relief Patch	MENTHOL	Veridian Healthcare	0ce356e0-90a3-ad52-e063-6294a90a404a	2024-04-18	Warnings	Exact identifier application number: M017
Walgreens Scalp Relief External analgesic	HYDROCORTISONE	Walgreen Company	da0a24c7-9295-4f22-b2c7-40000dad4b81	2024-04-18	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1442261	menthol 3 % Topical Cream	PSN	02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd	1
1442261	menthol 30 MG/ML Topical Cream	SCD	02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd	1
1442261	menthol 3 % Topical Cream	SY	02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70673-501-00	70673050100	60 mL in 1 BOTTLE (70673-501-00)	60 ml	2024-06-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SMOOTH GATOR Head-Ezz Topical Analgesic Cream	Smooth Gator LLC \| Pure Source, LLC	2024-06-10	HUMAN OTC DRUG LABEL	1