Sarna

Product NDC: 0316-0230
11-digit product format: 003160230
Labeler code: 0316
Product ID: 0316-0230_48341fc1-10ea-47fa-e063-6394a90abe32
Type: HUMAN OTC DRUG
Nonproprietary name: Pramoxine Hydrochloride
Dosage form: LOTION
Route: TOPICAL
Labeler: Crown Laboratories
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-01-01
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0316-0230		D	Discontinued by firm		2026-08-17
excluded package	package	0316-0230	0316-0230-75	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0316-0230		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0316-0230	0316-0230-75	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sarna
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1246075	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
19b0ce1b-e147-01a1-e063-6394a90af808	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0316-0230-75	2023-02-13	C162847	48780-1	f386c64a-0288-0266-e053-dadaa90a7c1a	Sarna Sensitive
0316-0230-75	2023-01-30	C162847	48780-1	f386c64a-0288-0266-e053-dadaa90a7c1a	Sarna Sensitive

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0316-0230-12	Sarna	355 mL in 1 BOTTLE, PUMP	LOTION	355	5
0316-0230-25	Sarna	5 mL in 1 PACKET	LOTION	5	5
0316-0230-57	Sarna	222 mL in 1 BOTTLE, PUMP	LOTION	222	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0316-0230-75	ML - Milliliter	0316-0230	c47fd8d6-cdae-4078-8f6f-5cdc699dcd3b	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0316-0230	SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [CROWN LABORATORIES]	20	Current NDC, Legacy NDC	20240602_7b2ff573-ca59-d69a-e053-2a91aa0abcec.zip
0316-0230	SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [CROWN LABORATORIES]	2	Current NDC, Legacy NDC, 3 package rows	20250323_19b0ce1b-e147-01a1-e063-6394a90af808.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 155 · 3,098 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Inknows Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	59eb9c12-9e00-0171-e063-6394a90a8342	2026-08-25	Warnings	Exact identifier application number: M017
Lidomar	LIDOMAR	Oncora Pharma, LLC	215bfdca-60bf-480b-b02e-902de52fe5e8	2026-08-25	Warnings	Exact identifier application number: M017
HEEL PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	59c7e13f-b9ea-023a-e063-6294a90a79e0	2026-08-24	Warnings	Exact identifier application number: M017
KNEE PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	59c8b33a-7d4f-2c6e-e063-6394a90a7929	2026-08-24	Warnings	Exact identifier application number: M017
Bovonte Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5958cc29-c449-56a7-e063-6394a90a960b	2026-08-24	Warnings	Exact identifier application number: M017
JELVOXA NECK PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	59a3d60a-26b5-e6a6-e063-6294a90a42bd	2026-08-22	Warnings	Exact identifier application number: M017
JELVOXA DMSO	CAMPHOR CAPSAICIN MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	59a43e2c-d258-34b5-e063-6394a90a09bf	2026-08-22	Warnings	Exact identifier application number: M017
Capsaicin 0.035 Percent	CAPSAICIN	Preferred Pharmaceuticals Inc.	0fabc025-4208-45f5-b3c2-543ae3a2df41	2026-08-21	Warnings	Exact identifier application number: M017
Claravie	HYDROCORTISONE ACETATE	Gentell LLC	598d224b-d12e-89bf-e063-6394a90a84dc	2026-08-21	Warnings	Exact identifier application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING	MENTHOL, CAMPHOR	Worldwide Cosmetics, Inc	3b8c2419-7a78-2731-e054-00144ff8d46c	2026-08-21	Warnings	Exact identifier application number: M017
Enokon Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	5976e667-e506-1d11-e063-6394a90a6809	2026-08-20	Warnings	Exact identifier application number: M017
MQUPIN TIGER Patch	TIGER PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5977cbb5-94c7-cb24-e063-6294a90a2e07	2026-08-20	Warnings	Exact identifier application number: M017
MQUPIN Nicotine Patches	NICOTINE PATCHES	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5978258a-549e-50e6-e063-6394a90a3d86	2026-08-20	Warnings	Exact identifier application number: M017
Claravie	CAMPHOR	Gentell LLC	5978bdab-5359-be9a-e063-6394a90a5a32	2026-08-20	Warnings	Exact identifier application number: M017
Rugby PAIN RELIEF PATCHES	LIDOCAINE	RUGBY LABORATORIES	b34e40c8-a257-46cf-9399-f55df9b4102d	2026-08-20	Warnings	Exact identifier application number: M017
MAXIMUM STRENGTH Lidocaine Plus Menthol	LIDOCAINE, MENTHOL	ARMY AND AIR FORCE EXCHANGE SERVICE	60f72061-d264-424e-b396-5a609076d352	2026-08-20	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET PAIN RELIEF	5980c527-6bcb-a846-e063-6294a90a0788	2026-08-20	Warnings	Exact identifier application number: M017
Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Amerisource Bergen	5fb5e5ce-b268-4444-8b63-ea7ea6abf269	2026-08-20	Warnings	Exact identifier application number: M017
Dr. Scholls Blister Pain Relief Complete Kit	LIDOCAINE	Scholl's Wellness Company LLC	58c2b35c-e1ed-7ea8-e063-6294a90a1494	2026-08-19	Warnings	Exact identifier application number: M017
Dr. Scholls Blister Pain Relief Complete Kit	LIDOCAINE	Scholl's Wellness Company LLC	585e740b-e4fa-d2aa-e063-6294a90a0982	2026-08-19	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1246075	pramoxine HCl 1 % Topical Lotion	PSN	19b0ce1b-e147-01a1-e063-6394a90af808	5
1246075	pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	19b0ce1b-e147-01a1-e063-6394a90af808	5
1246075	pramoxine hydrochloride 1 % Topical Lotion	SY	19b0ce1b-e147-01a1-e063-6394a90af808	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0316-0230-12	00316023012	355 mL in 1 BOTTLE, PUMP (0316-0230-12)	355 ml	2024-01-01		No	No	Current
0316-0230-25	00316023025	5 mL in 1 PACKET (0316-0230-25)	5 ml	2024-03-18		Yes	No	Current
0316-0230-57	00316023057	222 mL in 1 BOTTLE, PUMP (0316-0230-57)	222 ml	2024-01-01		No	No	Current
0316-0230-75	00316023075	222 mL in 1 BOTTLE, PUMP (0316-0230-75)	222 ml	2018-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sarna Sensitive	Crown Laboratories \| Crown Laboratories, Inc.	2026-01-12	HUMAN OTC DRUG LABEL	5
Sarna Sensitive	Crown Laboratories \| Crown Laboratories, Inc.	2024-05-31	HUMAN OTC DRUG LABEL	20