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 17 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DCH Rapid Relief Hemorrhoidal	LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Derma Care Research Labs	00eef84c-a72e-3343-e063-6294a90aa4d8	2024-12-19	Warnings	Exact identifier application number: M015
Formula 2 Skin Care	LIDOCAINE 5%	Derma Care Research Labs	a05d5e07-ae4b-38cc-e053-2a95a90abced	2024-12-19	Warnings	Exact identifier application number: M015
Revivol Hemorrhoid and Fissure	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Derma Care Research Labs, LLC	0140cf68-b6a0-4378-e063-6394a90afee8	2024-12-19	Warnings	Exact identifier application number: M015
Hemorroidal Cooling gel	PHENYLEPHRINE, WITCH HAZEL	Trifecta Pharmaceuticals Usa Llc	651c0143-384c-3649-e053-2991aa0a0f28	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	c50cc6ad-e8a0-47c1-e053-2a95a90a4de6	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	fe18fa61-83f9-8bf9-e053-6294a90a7585	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	c59dcb2a-392b-670b-e053-2995a90a9682	2024-12-18	Warnings	Exact identifier application number: M015
TheraCare Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Veridian Healthcare	fab95657-d257-e671-e053-6294a90a59e0	2024-12-18	Warnings	Exact identifier application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal Pads	WITCH HAZEL	Dickinson Brands Inc.	1b50f4dc-c26a-431a-ae18-c43513871b39	2024-12-18	Warnings	Exact identifier application number: M015
RECTICARE	LIDOCAINE	Ferndale Laboratories, Inc.	49cb48cf-7a26-4d7a-887f-2e98261d269d	2024-12-17	Warnings	Exact identifier application number: M015
Recticare Advanced	LIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUM	Ferndale Laboratories, Inc.	209212a7-7b6e-4b26-9f31-0eeb76f026bf	2024-12-17	Warnings	Exact identifier application number: M015
RECTICARE	LIDOCAINE AND GLYCERIN	Ferndale Laboratories, Inc.	2b94136a-4975-2925-e054-00144ff88e88	2024-12-17	Warnings	Exact identifier application number: M015
PRAX	PRAMOXINE HYDROCHLORIDE	Ferndale Laboratories, Inc.	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	2024-12-17	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Rugby	a5b5e0a9-eee9-2a1e-e053-2a95a90a464e	2024-12-17	Warnings	Exact identifier application number: M015
Warrior Rectal Care	LIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Derma Care Research Labs	fc10cbc3-fc1b-ae09-e053-6394a90ac8f3	2024-12-15	Warnings	Exact identifier application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)	GLYCERIN, LIDOCAINE, AND WITCH HAZEL	Blistex Inc	a7cb6d78-3048-43b3-afe7-4d862fdcfd3f	2024-12-13	Warnings	Exact identifier application number: M015
Tucks Medicated Cooling Pads	WITCH HAZEL	Blistex Inc	b3e68008-3d0d-4124-9579-b503e9fb95c9	2024-12-13	Warnings	Exact identifier application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal Relief	WITCH HAZEL	Dickinson Brands Inc.	2a4273a4-3bda-4653-a065-cd4578053f3c	2024-12-12	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	Medical Products Laboratories, Inc.	b815792f-2f8f-7ac8-e053-2995a90ade18	2024-12-11	Warnings	Exact identifier application number: M015
Zensa	LIDOCAINE	Alera Skin Care Products Inc.	f56146b6-3c11-4608-a6ab-6142f27e9ac3	2024-11-24	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