Ultra Balm

Product NDC: 57598-888
11-digit product format: 575980888
Labeler code: 57598
Product ID: 57598-888_46879b8b-9d05-4457-99ad-ddd77d90ceb7
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol and Methyl Salicylate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Ling Nam Medicine Factory (H.K.) Ltd.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-08-01
Substance: MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength: 140; 232 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 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
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57598-888	57598-888-25	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Ultra Balm
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	140 mg/g
METHYL SALICYLATE	232 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
LAV5U5022Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1433200	Internal RxNorm lookup
1433205	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
de997baf-aa04-474e-b912-3fc67e720d0b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57598-888-07	Ultra Balm	19.8 g in 1 JAR	OINTMENT	19.8	9
57598-888-07	Ultra Balm	1 in 1 CARTON	OINTMENT	1	9
57598-888-23	Ultra Balm	65.1 g in 1 JAR	OINTMENT	65.1	9
57598-888-23	Ultra Balm	1 in 1 CARTON	OINTMENT	1	9
57598-888-88	Ultra Balm	65.1 g in 1 JAR	OINTMENT	65.1	9
57598-888-88	Ultra Balm	1 in 1 CARTON	OINTMENT	1	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]	1
Methyl Salicylate	ACTIVE INGREDIENT	LAV5U5022Y	ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]	1
Eucalyptus Oil	INACTIVE INGREDIENT	2R04ONI662	ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]	1
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]	1
Paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]	1
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]	1
Thyme Oil	INACTIVE INGREDIENT	2UK410MY6B	ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57598-888	ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]	9	Current NDC, Legacy NDC, 6 package rows	20240724_de997baf-aa04-474e-b912-3fc67e720d0b.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 114 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medicaine Sting and Bite	BENZOCAINE	James Alexander Corporation	753e6cbe-31e0-4017-93d0-8b4bf5972f37	2024-12-09	Warnings	Exact identifier application number: M017
AUVON Pain Relief Roll-on	MENTHOL	SHENZHEN YUWEN E-COMMERCE CO., LTD.	df239c4d-af6a-41ca-baed-d0788782ce9f	2024-12-08	Warnings	Exact identifier application number: M017
AUVON Pain Relief Roll-on	LIDOCAINE	SHENZHEN YUWEN E-COMMERCE CO., LTD.	8b30f623-6077-4f2e-8fa4-ce4a298953b5	2024-12-08	Warnings	Exact identifier application number: M017
QC Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Chain Drug Marketing Association	b5e41e3a-81df-3a63-e053-2a95a90a5839	2024-12-08	Warnings	Exact identifier application number: M017
QC Lidocaine Maximum Strength	LIDOCAINE HCL	Chain Drug Marketing Association	b5e1b1ab-8a95-2d2d-e053-2995a90aea53	2024-12-08	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	Alexso, Inc	433da27d-04fb-481a-bbb0-874bb72c806a	2024-12-06	Warnings	Exact identifier application number: M017
POMG PAIN RELIEF BODY	LIDOCAINE	POMG LLC	28d7ac46-b27f-43bb-e063-6294a90a93ed	2024-12-06	Warnings	Exact identifier application number: M017
Capsaicin 0.1 Percent	CAPSAICIN	Alexso, Inc	0090ca38-6433-45c4-9453-edf2788c14c6	2024-12-06	Warnings	Exact identifier application number: M017
Signature Care Menthol	MENTHOL 4%	Safeway	27d3cb47-a6c7-5b7a-e063-6394a90a056f	2024-12-05	Warnings	Exact identifier application number: M017
ITCH X	BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE	BF ASCHER AND CO INC	03c16d33-8f59-0184-e054-00144ff8d46c	2024-12-05	Warnings	Exact identifier application number: M017
PO First Aid Series BURN	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	f1c349a8-216d-4233-922e-c95329a33d1e	2024-12-05	Warnings	Exact identifier application number: M017
Post Treatment Balm	HYDROCORTISONE	Allure Labs Inc.	faa803e6-453c-4d86-85dd-5a5dcdd72d02	2024-12-05	Warnings	Exact identifier application number: M017
CBD Pain Relief Cream	TROLAMINE SALICYLATE	Allure Labs	b6b3102a-4154-2da2-e053-2995a90ae99f	2024-12-05	Warnings	Exact identifier application number: M017
CVS Health Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATE	Natural Essentials, Inc.	f7198485-3d68-41d2-b9b9-f932a0649310	2024-12-04	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Hisamitsu America, Inc.	364924d3-fac3-4f4e-9b40-decd4ec48245	2024-12-03	Warnings	Exact identifier application number: M017
Bite and Itch	DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	Weeks & Leo Co., Inc.	0a4d471b-c3f3-0a6a-e063-6394a90ad57b	2024-12-03	Warnings	Exact identifier application number: M017
Menthol	AMISH ORIGINS MEDICATED	Amish Origins LLC	547abe39-3af3-4d70-99dd-caf8d67feda2	2024-12-03	Warnings	Exact identifier application number: M017
Meijer Small Cold-Hot Medicated Patches	MENTHOL	Meijer Distribution Inc	be6012d6-2062-45ba-8fc4-abf14cff5845	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	acdd5622-a9a7-4cc3-877e-57efea23303f	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5	2024-12-03	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
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1433205	LING NAM ULTRA BALM 14 % / 23.2 % Topical Ointment	PSN	de997baf-aa04-474e-b912-3fc67e720d0b	9
1433200	menthol 14 % / methyl salicylate 23.2 % Topical Ointment	PSN	de997baf-aa04-474e-b912-3fc67e720d0b	9
1433205	menthol 0.14 MG/MG / methyl salicylate 0.232 MG/MG Topical Ointment [Ling Nam Ultra Balm]	SBD	de997baf-aa04-474e-b912-3fc67e720d0b	9
1433200	menthol 0.14 MG/MG / methyl salicylate 0.232 MG/MG Topical Ointment	SCD	de997baf-aa04-474e-b912-3fc67e720d0b	9
1433205	Ling Nam Ultra Balm (menthol 14 % / methyl salicylate 23.2 % ) Topical Ointment	SY	de997baf-aa04-474e-b912-3fc67e720d0b	9
1433200	menthol 14 % / methyl salicylate 23.2 % Topical Ointment	SY	de997baf-aa04-474e-b912-3fc67e720d0b	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57598-888-07	57598088807	1 JAR in 1 CARTON (57598-888-07) / 19.8 g in 1 JAR	1 jar	2013-08-01	0000-00-00	No	No	Current
57598-888-23	57598088823	1 JAR in 1 CARTON (57598-888-23) / 65.1 g in 1 JAR	1 jar	2017-09-19	0000-00-00	No	No	Current
57598-888-88	57598088888	1 JAR in 1 CARTON (57598-888-88) / 65.1 g in 1 JAR	1 jar	2022-01-07	0000-00-00	No	No	Current