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		2026-09-14
excluded package	package	0316-0230	0316-0230-75	D	Discontinued by firm		2026-09-14

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 157 · 3,129 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JenGufun LIDOCAINE KNEE Patch	LIDOCAINE KNEE PATCH	Henan Kangdi Medical Devices Co., Ltd.	5b1d8508-b993-7a8d-e063-6294a90ae306	2026-09-10	Warnings	Exact identifier application number: M017
Wart Corn Remover	SALICYLIC ACID	HONG KONG FOREVER YOUNG TRADING CO., LIMITED	5b0cd6e0-f220-4ebd-e063-6294a90ade67	2026-09-09	Warnings	Exact identifier application number: M017
Magic Cream	PAIN RELIEVING OINTMENT	Jiangxi Baikang Medical Products Co., Ltd.	5b0f2515-47e9-603f-e063-6294a90af9d4	2026-09-09	Warnings	Exact identifier application number: M017
Burn Gel	LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	e9d3e9be-1036-fad0-e053-2a95a90a6efe	2026-09-09	Warnings	Exact identifier application number: M017
4% Lidocaine Pain Relief Patch	LIDOCAINE 4%	Guangxi Keyun E-commerce Co., Ltd.	5b197cd8-542f-38b4-e063-6294a90ad7d3	2026-09-09	Warnings	Exact identifier application number: M017
Pain Relieving Lidocaine Patch	LIDOCAINE	YYBA CORP	af8c84fd-224c-72b3-e053-2a95a90a9568	2026-09-07	Warnings	Exact identifier application number: M017
American Safety First Aid	LIDOCAINE HCL	Orazen Inc	ea2f776b-dfd0-6ce4-e053-2995a90af009	2026-09-07	Warnings	Exact identifier application number: M017
MEDI-FIRST Topical Analgesic	LIDOCAINE HCI	Ultra Distributors Inc	b6f288f7-9ae3-215e-e053-2a95a90aedf6	2026-09-07	Warnings	Exact identifier application number: M017
MEDI-FIRST	BENZALKONIUM CHLORIDE, LIDOCAINE	Orazen Inc	f508434f-5948-7134-e053-2a95a90a03d7	2026-09-05	Warnings	Exact identifier application number: M017
MEDI-FIRST	BENZALKONIUM CHLORIDE, LIDOCAINE	Orazen Inc	f522fb0b-3d86-b228-e053-2a95a90a55e9	2026-09-05	Warnings	Exact identifier application number: M017
SurviveX Anti-itch Cream	SURVIVEX HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	5a7a1141-d3b1-0ee8-e063-6294a90a16aa	2026-09-04	Warnings	Exact identifier application number: M017
NeuroNesic Pain Relieving Cream	CAPSAICIN	Blaine Labs Inc.	7107c13d-bf59-4c0a-84fe-725a9fca2691	2026-09-04	Warnings	Exact identifier application number: M017
FREEZE EASE	MENTHOL 4%	Global America Group LLC	16553eda-ec34-485a-a11c-f51260efd9fa	2026-09-03	Warnings	Exact identifier application number: M017
Neoteric Diabetic Skin Care 1 oz.	DIMETHICONE	RNA PHARMA LLC	5a944486-9591-f583-e063-6394a90aa04b	2026-09-03	Warnings	Exact identifier application number: M017
Equate Menthol Pain Relieving	MENTHOL	Wal-Mart Stores Inc	d5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc	2026-09-03	Warnings	Exact identifier application number: M017
ZHI Technologies	LIDOCAINE, MENTHOL	ZHI Technologies, Inc.	6717e995-4d2d-49e8-8ecf-7c62557dfdef	2026-09-03	Warnings	Exact identifier application number: M017
Komxsum LIDOCAINE Cream	LIDOCAINE 4% CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5a9feae0-9be4-e736-e063-6294a90abe55	2026-09-03	Warnings	Exact identifier application number: M017
FREEZE EASE Roll-On	MENTHOL	Global America Group LLC	1869cc0d-a056-45de-aede-23b09b61ed12	2026-09-02	Warnings	Exact identifier application number: M017
Gaimoa Lidocaine Pain Relief Gel Patches	LIDOCAINE PAIN RELIEF GEL PATCHES	Henan Enokon Medical Instrument Co., Ltd.	5a68fe67-5c15-af9a-e063-6294a90a7ec1	2026-09-01	Warnings	Exact identifier application number: M017
CVS Cortisone Liquid	HYDROCORTISONE	CVS Pharmacy	42df45a9-d449-090a-e063-6394a90a9ee4	2026-09-01	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