Fresh Start

Product NDC: 63830-950
11-digit product format: 638300950
Labeler code: 63830
Product ID: 63830-950_518cee25-e259-0a55-e063-6394a90a4ea0
Type: HUMAN OTC DRUG
Nonproprietary name: CHLOROXYLENOL
Dosage form: SOAP
Route: TOPICAL
Labeler: Pro Chem, Inc.
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-04-20
Substance: CHLOROXYLENOL
Active strength: 3 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	63830-950		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63830-950	63830-950-06	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: Fresh Start
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLOROXYLENOL	3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0F32U78V2Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
413261	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
dd1708d8-0bb2-c96a-e053-2995a90a5b86	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63830-950-06	Fresh Start	1 in 1 BOX	SOAP	1		3
63830-950-06	Fresh Start	800 mL in 1 BAG	SOAP	800		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63830-950	FRESH START (CHLOROXYLENOL) SOAP [PRO CHEM, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20250114_dd1708d8-0bb2-c96a-e053-2995a90a5b86.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 6 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Water-Jel Neomycin Antibiotic	FIRST AID OINTMENT	Water-Jel Technologies	abea91a2-4453-406d-a7ed-3ffc19ef521a	2025-12-31	Warnings	Exact identifier application number: M004
Caring Mill Triple Antibiotic and Pain	PRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE	FSA Store Inc. (Caring Mills)	3c5b6909-6b30-5256-e063-6294a90a9096	2025-12-29	Warnings	Exact identifier application number: M004
Caring Mills Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Veridian Healthcare	fbd11419-4513-10d7-e053-6394a90ac82b	2025-12-27	Warnings	Exact identifier application number: M004
Caring Mill Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Veridian Healthcare	8cd0cd64-fe62-4225-8986-5e8641dd6df2	2025-12-22	Warnings	Exact identifier application number: M004
PS-2261 Triple Antibiotic, 0.5g	PS-2261 TRIPLE ANTIBIOTIC, 0.5G	ProStat First Aid LLC	0072f8de-fc06-d529-e063-6294a90a08db	2025-12-15	Warnings	Exact identifier application number: M004
PS - 2895 Triple Antibiotic , 0.5g	PS - 2895 TRIPLE ANTIBIOTIC , 0.5G	Prostat First Aid LLC	0050de33-914b-f76d-e063-6394a90a7fab	2025-12-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	TRIPLE ANTIBIOTIC	ProStat First Aid	f76d7d18-0fa1-d943-e053-6294a90ac20a	2025-12-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	TRIPLE ANTIBIOTIC	Front Line Safety	0f509f96-a083-37d1-e063-6394a90a622c	2025-12-15	Warnings	Exact identifier application number: M004
ElixirTripleGuard Triple Antibiotic	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B	ELIXIR HEALTHCARE USA, LLC.	43edfb80-4d50-9362-e063-6394a90a2199	2025-12-13	Warnings	Exact identifier application number: M004
El Valle Decolorized Iodine	ALCOHOL	Pharmadel LLC	fd7a227b-536c-b3f7-e053-6394a90a4158	2025-12-04	Warnings	Exact identifier application number: M004
Vitastem First Aid Antibiotic	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	3970ac49-ab0f-4492-ba61-95a12faed500	2025-12-02	Warnings	Exact identifier application number: M004
Thera Plus Original Strength Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Fourstar Group USA, Inc	2f916502-4daf-4cb9-a638-f37bb96c8077	2025-12-02	Warnings	Exact identifier application number: M004
CAREALL Bacitracin	BACITRACIN ZINC	New World Imports, Inc	ea16e1de-0100-456b-abe6-d33de78221da	2025-12-02	Warnings	Exact identifier application number: M004
Triple Antibiotic Ointment, Circle K	TRIPLE ANTIBIOTIC OINTMENT	Lil' Drug Store Products, Inc.	44e5107e-832a-2ce6-e063-6294a90a711d	2025-12-01	Warnings	Exact identifier application number: M004
Viaderma Care First Aid Antibiotic	BACITRACIN ZINC	VIADERMA DISTRIBUTION INC	0f36f396-e479-486c-b047-2760477609e2	2025-12-01	Warnings	Exact identifier application number: M004
CareALL Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	New World Imports, Inc	1982b664-e8fd-4030-aa89-f7543e1b487b	2025-12-01	Warnings	Exact identifier application number: M004
CareALL Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	New World Imports, Inc	9c2d417e-6fec-42f4-9f0c-2ec79de9342d	2025-12-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Bryant Ranch Prepack	5b0249c0-c196-4d3c-973f-49bd2d3d4a75	2025-12-01	Warnings	Exact identifier application number: M004
Neosporin Plus Lidocaine	BACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINE	Kenvue Brands LLC	e450b6a1-a8da-e5db-e053-2995a90a0ef0	2025-11-24	Warnings	Exact identifier application number: M004
ElixirZincoCare	ZINC OXIDE 20%	ELIXIR HEALTHCARE USA, LLC.	bac18496-3b76-4faf-abde-968d79b718d8	2025-11-22	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0F32U78V2Q	CHLOROXYLENOL	88-04-0	CHLOROXYLENOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
413261	chloroxylenol 0.3 % Medicated Liquid Soap	PSN	dd1708d8-0bb2-c96a-e053-2995a90a5b86	3
413261	chloroxylenol 3 MG/ML Medicated Liquid Soap	SCD	dd1708d8-0bb2-c96a-e053-2995a90a5b86	3
413261	chloroxylenol 0.3 % Medicated Liquid Soap	SY	dd1708d8-0bb2-c96a-e053-2995a90a5b86	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63830-950-06	63830095006	1 BAG in 1 BOX (63830-950-06) / 800 mL in 1 BAG	1 bag	2022-04-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fresh Start 6544 Drug Facts and Label	Pro Chem, Inc. \| ABC Compounding Co., Inc.	2026-05-11	HUMAN OTC DRUG LABEL	3