Rugby Ice Blue

Product NDC: 0536-1061
11-digit product format: 005361061
Labeler code: 0536
Product ID: 0536-1061_3a605963-eddd-4402-b75c-a308ef688cb0
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, UNSPECIFIED FORM
Dosage form: GEL
Route: TOPICAL
Labeler: Rugby Laboratories
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-01-20
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 20 mg/g
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	0536-1061		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0536-1061	0536-1061-39	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`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: Rugby Ice Blue
Brand name suffix: External Analgesic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	20 mg/g

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
311502	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
2b65cb6a-4364-4770-b7b9-5c4637edd01a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0536-1061-39	2020-03-20	C162847	48780-1	9d75b9d1-09ed-f424-e053-dadaa90a57ce	Rugby ® Ice Blue Gel External Analgesic
0536-1061-39	2020-01-31	C162847	48780-1	9d75b9d1-09ed-f424-e053-dadaa90a57ce	Rugby ® Ice Blue Gel External Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0536-1061-39	Rugby Ice BlueExternal Analgesic	226.8 g in 1 JAR	GEL	226.8		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1061-39	GM - Gram	0536-1061	e9f23715-1a08-496d-8632-9ca7714b1fc9	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1
Ammonia	INACTIVE INGREDIENT	5138Q19F1X	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1
Cupric Sulfate	INACTIVE INGREDIENT	LRX7AJ16DT	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1
Magnesium Sulfate Anhydrous	INACTIVE INGREDIENT	ML30MJ2U7I	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1
Thymol	INACTIVE INGREDIENT	3J50XA376E	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-1061	RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) GEL [RUGBY LABORATORIES, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240316_2b65cb6a-4364-4770-b7b9-5c4637edd01a.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 7 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	2026-07-30	Warnings	Exact identifier application number: M017
Icy Hot Performance No-Mess Pain Relief Cream	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	5e3e272a-c001-4f57-9535-521ccc85ae65	2026-07-30	Warnings	Exact identifier application number: M017
Auixudin Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bc7b9e-e2f7-724b-e063-6394a90ab36f	2026-07-29	Warnings	Exact identifier application number: M017
Jinfahe Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bcd9c5-767e-b634-e063-6394a90a2878	2026-07-29	Warnings	Exact identifier application number: M017
Maximun Strength Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Meijer Distribution Inc	d0468514-58ea-4d8f-b634-a65bf95c0316	2026-07-29	Warnings	Exact identifier application number: M017
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	57ca9220-2778-790a-e063-6294a90af506	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine No-Mess plus Lavender	LIDOCAINE HCL	Chattem, Inc.	3948a3d2-ce04-4703-8709-211e75c9c38d	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Professional Cream	LIDOCAINE HCL 4%	Chattem, Inc.	ef297864-5917-4645-8ec7-f2bc49e037e8	2026-07-29	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Clinic Pharma	cdfd6b39-b430-4e95-a0f7-682cf3d78b52	2026-07-28	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Clinic Pharma	2b4d2105-b7ad-2695-e063-6394a90a999b	2026-07-28	Warnings	Exact identifier application number: M017
HEMPE Ice Muscle and Joint Gel	MENTHOL	Healthcare International Research Limited	57aec922-1de4-c579-e063-6394a90af6c8	2026-07-28	Warnings	Exact identifier application number: M017
Earths Care Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	DLC Laboratories, Inc.	5c3976da-a6cb-4b94-ae41-3e86b1ab13cb	2026-07-28	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Preferred Pharmaceuticals Inc.	9e7568b6-52ae-4f7a-9bfd-503fd80a297e	2026-07-28	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine with Rosemary and Mint	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	9d40bfea-85d0-4943-83e9-0c16e79a011c	2026-07-28	Warnings	Exact identifier application number: M017
KENS PAIN AND ARTHRITIS FORMULA	MENTHOL	Eezaway Relief Inc	35834473-3ad5-41ec-a110-e742aa7e2ee4	2026-07-28	Warnings	Exact identifier application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream	LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57935b64-6e2e-85d0-e063-6394a90a7428	2026-07-27	Warnings	Exact identifier application number: M017
1% Hydrocortisone Anti-itch	1% HYDROCORTISONE ANTI-ITCH	ALAINA HEALTHCARE PRIVATE LIMITED	b8416467-55f7-4e5f-a5cb-3abd3e2bb577	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	57984bc2-bf1d-c423-e063-6394a90a06ae	2026-07-27	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311502	menthol 2 % Topical Gel	PSN	2b65cb6a-4364-4770-b7b9-5c4637edd01a	5
311502	menthol 0.02 MG/MG Topical Gel	SCD	2b65cb6a-4364-4770-b7b9-5c4637edd01a	5
311502	menthol 2 % Topical Gel	SY	2b65cb6a-4364-4770-b7b9-5c4637edd01a	5
311502	menthol 2 % topical stick	SY	2b65cb6a-4364-4770-b7b9-5c4637edd01a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-1061-39	00536106139	226.8 g in 1 JAR (0536-1061-39)	226.8 g	2015-01-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rugby ® Ice Blue Gel External Analgesic	Rugby Laboratories \| Garcoa, Inc.	2024-03-14	HUMAN OTC DRUG LABEL	5