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		2026-10-23
excluded package	package	0316-0230	0316-0230-75	D	Discontinued by firm		2026-10-23

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…`

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: 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 16 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Ice Extreme Dry Stick	MENTHOL	Carlin Consumer Health LLC	4f81be91-92e5-1205-e063-6394a90a6e82	2026-06-02	Warnings	Exact identifier application number: M017
Kalaya Extra Strength Pain Relief Gel with Arnica	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	b6a6237d-b471-4102-b5df-fc389f5f9258	2026-06-02	Warnings	Exact identifier application number: M017
Biofreeze Ultraflex	LIDOCAINE	Reckitt Benckiser LLC	2655974b-a67d-9f07-e063-6294a90a54e8	2026-06-02	Warnings	Exact identifier application number: M017
Biofreeze Ultraflex Plus	LIDOCAINE, MENTHOL	Reckitt Benckiser LLC	401e1843-e9a6-fda9-e063-6294a90a3073	2026-06-02	Warnings	Exact identifier application number: M017
Pain Relief	MENTHOL SPRAY	Owell Naturals Brand, LLC	534c871c-da35-6135-e063-6294a90aa9f6	2026-06-02	Warnings	Exact identifier application number: M017
Charm Tex FLUORIDE Gel	SODIUM FLUORIDE	Jiangsu Gold Worldworks Household Chemicals Co., Ltd.	09d47bd7-1438-4ef2-85e0-9cd5eb2f763a	2026-05-31	Warnings	Exact identifier application number: M017
Charm Tex FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Jiangsu Gold Worldworks Household Chemicals Co., Ltd.	2bddc69a-0c0f-47fc-bc98-90c2ec70dd6f	2026-05-31	Warnings	Exact identifier application number: M017
Sting Relief Prep Pad	BENZOCAINE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	9487d15d-9116-4ff8-a004-ba0835ea091e	2026-05-31	Warnings	Exact identifier application number: M017
Careland Kinesiology Pain Relieving Tape	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Planet (Anhui) Pharmaceutical Co., Ltd.	35d24cfc-9d34-4fd7-9312-1673b092a3b9	2026-05-31	Warnings	Exact identifier application number: M017
Walgreens Scalp Itch Relief	HYDROCORTISONE	Walgreens	34952272-1f9e-c642-e063-6394a90ae2bd	2026-05-29	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine No-Mess Applicator	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	8092cde7-28d0-4755-b5c0-5765934e572f	2026-05-29	Warnings	Exact identifier application number: M017
Belladona and Arnica	MENTHOL	Dannso Corp./d.b.a. Essential Products	fc4e63e4-cebc-49ff-8900-7238261d0fe0	2026-05-28	Warnings	Exact identifier application number: M017
Insect Sting Relief	BENZOCAINE, ALCOHOL	Hubei Fanjian Medical Product Co.,Ltd	f30401c1-961e-44dd-e053-2a95a90a69d6	2026-05-28	Warnings	Exact identifier application number: M017
Menthol plus Camphor Pain Relief	MENTHOL, CAMPHOR	Veridian Healthcare	4a054949-0889-7182-e063-6394a90aff5e	2026-05-28	Warnings	Exact identifier application number: M017
Antibacterial Lidocaine Wound Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	960bfe55-87f6-3e51-e053-2995a90a867d	2026-05-27	Warnings	Exact identifier application number: M017
MyDerm Medical 5 Lidocaine Numbing Roll-On	LIDOCAINE	Inspec Solutions	1d466be1-a780-462f-8dd4-87478da096aa	2026-05-27	Warnings	Exact identifier application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol	MENTHOL	Inspec Solutions LLC.	d427d623-c2fd-7d6b-e053-2995a90abdc3	2026-05-27	Warnings	Exact identifier application number: M017
Caldyphen Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Amerisource Bergen	d8802e56-649e-4494-86ee-7ca8841cc28b	2026-05-27	Warnings	Exact identifier application number: M017
Equate Itch Relief Gel	ITCH RELIEF GEL	Walmart, Inc	7d7bb750-017e-c60e-e053-2991aa0ad671	2026-05-26	Warnings	Exact identifier application number: M017
MyDerm Bite and Sting	BENZOCAINE	Medline Industries	bf45c4dd-5814-4602-b96b-f82a44948763	2026-05-26	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