Painzaway Pain Relieving Gel

Product NDC: 10578-135
11-digit product format: 105780135
Labeler code: 10578
Product ID: 10578-135_2927e7a0-4cb0-3592-e063-6294a90a9fac
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Indiana Botanic Gardens
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-04-19
Substance: MENTHOL
Active strength: 4.6 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Painzaway Pain Relieving Gel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	4.6 g/100g

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
1549850	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
dba1d268-ebab-0ac7-e053-2a95a90ad4b6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10578-135-05	Painzaway Pain Relieving Gel	57 g in 1 JAR	GEL	57		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10578-135	PAINZAWAY PAIN RELIEVING GEL (MENTHOL) GEL [INDIANA BOTANIC GARDENS]	2	Current NDC, Legacy NDC, 1 package rows	20241215_dba1d268-ebab-0ac7-e053-2a95a90ad4b6.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Painzaway Pain Relieving Gel	MENTHOL	Indiana Botanic Gardens	dba1d268-ebab-0ac7-e053-2a95a90ad4b6	2024-12-13	Warnings	Exact identifier ndc (product): 10578-135

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1549850	menthol 4.6 % Topical Gel	PSN	dba1d268-ebab-0ac7-e053-2a95a90ad4b6	2
1549850	menthol 0.046 MG/MG Topical Gel	SCD	dba1d268-ebab-0ac7-e053-2a95a90ad4b6	2
1549850	menthol 4.6 % Topical Gel	SY	dba1d268-ebab-0ac7-e053-2a95a90ad4b6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10578-135-05	10578013505	57 g in 1 JAR (10578-135-05)	57 g	2022-04-19	0000-00-00	No	No	Current