TerraFreeze Pain Relief

Product NDC: 71805-855
11-digit product format: 718050855
Labeler code: 71805
Product ID: 71805-855_09dc09a4-8c6f-1ab6-e063-6394a90a8b1d
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Beyond Derma, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-10-12
Substance: MENTHOL; METHYL SALICYLATE; HISTAMINE DIHYDROCHLORIDE
Active strength: 100; 100; .5 mg/g; mg/g; mg/g
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: TerraFreeze Pain Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	100 mg/g
METHYL SALICYLATE	100 mg/g
HISTAMINE DIHYDROCHLORIDE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
LAV5U5022Y	Internal UNII lookup
3POA0Q644U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1947261	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
81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2dae634-14ed-febf-08ee-93196433b5b7	Product name	9	20190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8	Product name	1	20140508
d394f843-7479-dc48-dbd3-232266c5548c	Product name	1	20140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71805-855-00	TerraFreeze Pain Relief	57 g in 1 PACKAGE	CREAM	57		2
71805-855-00	TerraFreeze Pain Relief	1 in 1 BOX	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71805-855	TERRAFREEZE PAIN RELIEF (MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE) CREAM [BEYOND DERMA, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20231112_81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677.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 137 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relieving Cooling	MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	3574d48a-b546-4ea7-b470-071bb328de64	2024-02-08	Warnings	Exact identifier application number: M017
Advil Targeted Relief	CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE	Haleon US Holdings LLC	16e6be21-7b43-443a-89ec-3bdf0ec0dfc1	2024-02-08	Warnings	Exact identifier application number: M017
POINT RELIEF COLD SPOT Pain Relieving	MENTHOL	FABRICATION ENTERPRISES	96f1d592-6cec-412e-a5fd-cf3c4f68644f	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	1c5eb3b3-79b3-472a-ae36-ec6a7dc72925	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	8eb3e7e2-26e5-430e-89aa-40a0367c637e	2024-02-07	Warnings	Exact identifier application number: M017
Nova Natura Topical Analgesic	CAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATE	SEYITLER KIMYA SANAYI ANONIM SIRKETI	abf00f73-f0b1-439e-85aa-bbce8a1ec920	2024-02-06	Warnings	Exact identifier application number: M017
Leader Burn Relief	LIDOCAINE	Cardinal Health	f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2	2024-02-06	Warnings	Exact identifier application number: M017
Pain Relieving Petro Carbo	PHENOL	J.R. Watkins, LLC.	050cf17d-3be7-45b9-8524-ad82af309a0e	2024-02-06	Warnings	Exact identifier application number: M017
White Cream	CAMPHOR (NATURAL) AND TURPENTINE OIL	J.R. Watkins, LLC.	e4de0734-59d5-478c-86ea-66fc2ba003e7	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving Roll-On	MENTHOL, UNSPECIFIED FORM	Safetec of America, Inc.	80118260-9c88-402d-9a90-ecfe62b4b54f	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL, UNSPECIFIED FORM	Safetec of America, Inc.	df512ce6-ce1b-434d-9571-fb2e1d76e1d0	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL	Safetec of America, Inc.	52ebf64d-095f-467e-bf51-dd8d33b58c7d	2024-02-05	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Safetec of America, Inc.	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	2024-02-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	79e3b0e7-4ba5-4b9d-a980-5b6f18dba802	2024-02-04	Warnings	Exact identifier application number: M017
HAV EZ Penetrating Pain Relief	MENTHOL	PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC	70006efc-9cc8-4490-b28c-fcb23b1737c4	2024-02-01	Warnings	Exact identifier application number: M017
Rugby Capsaicin External Analgesic	CAPSAICIN	Proficient Rx LP	7c733a30-5002-49e7-a6bd-7737a1d2461e	2024-02-01	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	ccb62898-b614-45b9-95ea-23e5e31893a8	2024-02-01	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	Proficient Rx LP	0b26d92f-9d0e-46d4-a8bc-75d6da5f6199	2024-02-01	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	c57d5f8e-5934-4cbb-999a-cdd55e5b105f	2024-02-01	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Proficient Rx LP	47e9fe84-bd0c-40ea-85de-e950bcacc557	2024-02-01	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE
3POA0Q644U	HISTAMINE DIHYDROCHLORIDE	56-92-8	HISTAMINE DIHYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1947261	histamine dihydrochloride 0.050 % / menthol 10 % / methyl salicylate 10 % Topical Cream	PSN	81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677	2
1947261	histamine dihydrochloride 0.5 MG/ML / menthol 100 MG/ML / methyl salicylate 100 MG/ML Topical Cream	SCD	81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677	2
1947261	histamine dihydrochloride 0.050 % / menthol 10 % / methyl salicylate 10 % Topical Cream	SY	81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71805-855-00	71805085500	1 PACKAGE in 1 BOX (71805-855-00) / 57 g in 1 PACKAGE	1 package	2017-10-12	0000-00-00	No	No	Current