SCALAR Pain Relief Cream

Product NDC: 80883-097
11-digit product format: 808830097
Labeler code: 80883
Product ID: 80883-097_0975eb87-fad5-1621-e063-6394a90a9880
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: CREAM
Route: TOPICAL
Labeler: Miracle Balance, LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-10-15
Substance: MENTHOL
Active strength: 50 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: SCALAR Pain Relief Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	50 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
1039690	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
52a13cfe-3f46-45f8-a5af-ce07ea5758e3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80883-097-00	SCALAR Pain Relief Cream	1 in 1 BOX	CREAM	1		4
80883-097-00	SCALAR Pain Relief Cream	59.1 mL in 1 JAR	CREAM	59.1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80883-097	SCALAR PAIN RELIEF CREAM (MENTHOL) CREAM [MIRACLE BALANCE, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20231106_52a13cfe-3f46-45f8-a5af-ce07ea5758e3.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 16 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calmoseptine	ANORECTAL OINTMENT	Calmoseptine Inc.	ff9539ed-d9ae-401d-adbc-df8f1d751431	2025-01-13	Warnings	Exact identifier application number: M015
Dibucaine	DIBUCAINE	Akron Pharma Inc.	60469e43-ab6f-46d3-a1df-00e58275f565	2025-01-12	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Chain Drug Marketing Association Inc.	2b490a08-149d-76ab-e063-6394a90a084f	2025-01-09	Warnings	Exact identifier application number: M015
Drs. pharmacy HEMORRHOIDAL COOLING	PHENYLEPHRINE HCL, WITCH HAZEL	OL PHARMA TECH, LLC Drs PHARMACY	d6f6b482-d85d-001c-e053-2995a90ad98c	2025-01-09	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream with Aloe	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Chain Drug Marketing Association	2b33c710-ac17-20f9-e063-6294a90ad29c	2025-01-08	Warnings	Exact identifier application number: M015
THE SOLUTION	LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE	SCALP TECH INC	df51623c-e0b6-8e86-e053-2995a90a59b2	2025-01-08	Warnings	Exact identifier application number: M015
frida mom Perineal Cooling Pad Liners	WITCH HAZEL	Fridababy, LLC	a461ff3d-e115-4f15-a545-bacb502ff6cd	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Postpartum Recovery Essentials	WITCH HAZEL	Fridababy, LLC	2d26c6f2-5d31-4c07-9f40-2fbfcfbf1234	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Perineal Healing	WITCH HAZEL	Fridababy, LLC	6a58e2a8-c4d5-4078-b5f4-28504de1f020	2024-12-30	Warnings	Exact identifier application number: M015
frida mom Labor and Delivery Plus Postpartum Recovery	WITCH HAZEL	Fridababy, LLC	4b5fc312-4c8c-4396-a70c-b1ed129038c7	2024-12-30	Warnings	Exact identifier application number: M015
Tucks Triple Relief Hemorrhoidal	WHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Blistex Inc.	bf892e90-2d9b-4fa0-8ee4-8a2736be6c30	2024-12-24	Warnings	Exact identifier application number: M015
BLISS GVS HEMORRHOIDAL	PHENYLEPHRINE HCL	Bliss GVS Pharma Limited	fceea303-2ea0-10e9-e053-6294a90a5492	2024-12-21	Warnings	Exact identifier application number: M015
Dibucaine	DIBUCAINE 1%	Geri-Care Pharmaceuticals, Corp	afe88610-5cac-960e-e053-2a95a90a7ba4	2024-12-20	Warnings	Exact identifier application number: M015
Hemorroidal Cooling gel	PHENYLEPHRINE, WITCH HAZEL	Pharmacy Value Alliance, LLC	7276aab8-0297-2a55-e053-2a91aa0a8d21	2024-12-20	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Pharmacy Value Alliance, LLC	3803a61b-308a-14a9-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M015
Bliss GVS Hemorrhoidal	HARD FAT, PHENYLEPHRINE HCL	Bliss GVS Pharma Limited	88c49f6c-2a48-2dae-e053-2a95a90af20a	2024-12-19	Warnings	Exact identifier application number: M015
Rectal Care Cream Revivol	LIDOCAINE 5%	Derma Care Research Labs	a1c75161-f84a-e996-e053-2a95a90ac0c5	2024-12-19	Warnings	Exact identifier application number: M015
DCH Numbing Relief	LIDOCAINE 5%	Derma Care Research Labs, LLC	ffd70a31-7d0c-d2d0-e053-6394a90a8674	2024-12-19	Warnings	Exact identifier application number: M015
DCH Hemorrhoidal	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Derma Care Research Labs, LLC	0050701f-4393-3f01-e063-6394a90a4e0e	2024-12-19	Warnings	Exact identifier application number: M015
Moshe Numbing Hemorrhoidal	LIDOCAINE 5%	Derma Care Research Labs	fbd5b488-1921-e9b7-e053-6294a90aba70	2024-12-19	Warnings	Exact identifier application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039690	menthol 5 % Topical Cream	PSN	52a13cfe-3f46-45f8-a5af-ce07ea5758e3	4
1039690	menthol 50 MG/ML Topical Cream	SCD	52a13cfe-3f46-45f8-a5af-ce07ea5758e3	4
1039690	menthol 5 % Topical Cream	SY	52a13cfe-3f46-45f8-a5af-ce07ea5758e3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80883-097-00	80883009700	1 JAR in 1 BOX (80883-097-00) / 59.1 mL in 1 JAR	1 jar	2020-10-15	0000-00-00	No	No	Current