Ivy Wash

Product NDC: 0395-0119
11-digit product format: 003950119
Labeler code: 0395
Product ID: 0395-0119_604fda97-cb16-13eb-e053-2991aa0aa452
Type: HUMAN OTC DRUG
Nonproprietary name: Pramoxine Hydrochloride
Dosage form: LOTION
Route: TOPICAL
Labeler: Humco Holding Group, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2008-01-01
Marketing end: 0000-00-00
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 10 1/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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0395-0119		I	Inactivated by FDA		2026-09-09
excluded package	package	0395-0119	0395-0119-96	I	Inactivated by FDA		2026-09-09

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0395-0119-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0395-0119-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0395-0119-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0395-0119-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0395-0119-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0395-0119-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0395-0119-96	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0395-0119-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0395-0119-96	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0395-0119-96	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0395-0119-96	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0395-0119-96	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0395-0119-96	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0395-0119-96	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0395-0119-96	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0395-0119-96	`fb8cb913e6d1…`	`eb8c232b6be0…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	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
0395-0119-96	2022-07-29	C162847	48780-1	e4f33bdf-9e43-d8a0-e053-dadaa90a6e4e	Ivy Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-0119-96	Ivy Wash	117 mL in 1 BOTTLE	LOTION	117		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-0119-96	ML - Milliliter	0395-0119	b066b61b-9951-4f5d-aef4-c0fcf6a304a4	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
AMMONIUM LAURYL SULFATE	INACTIVE INGREDIENT	Q7AO2R1M0B	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
HYDROLYZED JOJOBA ESTERS (ACID FORM)	INACTIVE INGREDIENT	UDR641JW8W	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
NONOXYNOL-9	INACTIVE INGREDIENT	48Q180SH9T	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-0119	IVY WASH (PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]	2	Legacy NDC, 1 package rows	20171214_3323f8fe-5219-4e3d-9622-3680d60555a5.zip

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
1247251	pramoxine HCl 1 % Medicated Liquid Soap	PSN	3323f8fe-5219-4e3d-9622-3680d60555a5	2
1247251	pramoxine hydrochloride 10 MG/ML Medicated Liquid Soap	SCD	3323f8fe-5219-4e3d-9622-3680d60555a5	2
1247251	pramoxine hydrochloride 1 % Medicated Liquid Soap	SY	3323f8fe-5219-4e3d-9622-3680d60555a5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-0119-96	00395011996	117 mL in 1 BOTTLE (0395-0119-96)	117 ml	2017-12-14	0000-00-00	No	No	Current