NuDroxicin pain relief Roll-On

Product NDC: 70859-028
Requested package NDC: 70859-028-03
11-digit product format: 708590028
Labeler code: 70859
Product ID: 70859-028_5e75e73e-0613-489d-e053-2a91aa0aa797
Type: HUMAN OTC DRUG
Nonproprietary name: METHYL SALICYLATE, MENTHOL, CAPSAICIN
Dosage form: LIQUID
Route: TOPICAL
Labeler: NuCare Pharmaceuticals Inc
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-11-18
Marketing end: 0000-00-00
Substance: METHYL SALICYLATE; MENTHOL; CAPSAICIN
Active strength: 250 mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70859-028	70859-028-03	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70859-028-03	2024-01-30	C162847	48780-1	1030e365-47e8-111a-e063-dadaa90a10e2	NuDroxicin pain relief Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70859-028-03	NuDroxicin pain relief Roll-On	90 mL in 1 CONTAINER	LIQUID	90		2
70859-028-03	NuDroxicin pain relief Roll-On	1 in 1 CARTON	LIQUID	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70859-028-03	ML - Milliliter	70859-028	9b0c060c-caec-4924-b4aa-7d75a275772b	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70859-028	NUDROXICIN PAIN RELIEF ROLL-ON (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LIQUID [NUCARE PHARMACEUTICALS INC]	2	Legacy NDC, 2 package rows	20180207_6492c511-c483-c337-e053-2a91aa0a3916.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1989491	capsaicin 0.025 % / menthol 6 % / methyl salicylate 25 % Topical Solution	PSN	6492c511-c483-c337-e053-2a91aa0a3916	2
1989491	capsaicin 0.25 MG/ML / menthol 60 MG/ML / methyl salicylate 250 MG/ML Topical Solution	SCD	6492c511-c483-c337-e053-2a91aa0a3916	2
1989491	capsaicin 0.025 % / menthol 6 % / methyl salicylate 25 % Topical Solution	SY	6492c511-c483-c337-e053-2a91aa0a3916	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70859-028-03	70859002803	1 CONTAINER in 1 CARTON (70859-028-03) > 90 mL in 1 CONTAINER	1 container	2018-02-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NuDroxiPAK	NuCare Pharmaceuticals,Inc.	2021-07-28	HUMAN PRESCRIPTION DRUG LABEL	4
NuDroxiPAK E-400 - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-05-07	HUMAN PRESCRIPTION DRUG LABEL	2
DFS 75mg DR/MS 25%/MENTH 6%/CAP 0.025% PAK - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-05-07	HUMAN PRESCRIPTION DRUG LABEL	2
NuDroxiPAK M-15	NuCare Pharmceuticals,Inc.	2021-05-04	HUMAN PRESCRIPTION DRUG LABEL	3
NuDroxiPAK DSDR-50	NuCare Pharmaceuticals, Inc.	2021-05-04	HUMAN PRESCRIPTION DRUG LABEL	2
NuDroxiPAK DSDR-75 - NuCare Pharmaceuticals,Inc. \| NuCare Pharmceuticals,Inc.	NuCare Pharmaceuticals,Inc. \| NuCare Pharmceuticals,Inc.	2021-05-04	HUMAN PRESCRIPTION DRUG LABEL	2
NuDroxiPAK N-500 - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-05-04	HUMAN PRESCRIPTION DRUG LABEL	2
DFS 1.5%/MS 25%/MENTH 6%/CAP 0.025% PAK	Nucare Pharmaceuticals Inc \| NuCare Pharmaceuticals,Inc.	2021-05-04	HUMAN PRESCRIPTION DRUG LABEL	2
NuDroxicin pain relief Roll-On	NuCare Pharmaceuticals Inc	2018-02-06	HUMAN OTC DRUG LABEL	2
NuDroxicin pain relief Roll-On	NuCare Pharmaceuticals Inc	2017-11-20	HUMAN OTC DRUG LABEL	2