PHM Safe

Product NDC: 78759-001
Requested package NDC: 78759-001-04
11-digit product format: 787590001
Labeler code: 78759
Product ID: 78759-001_0e8ec1ff-09b0-4bff-a738-a701eb7e93e4
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: SOLUTION
Route: TOPICAL
Labeler: PHM Brands, LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-09-14
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 80 L/100L
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	78759-001	78759-001-04	I	Inactivated by FDA		2026-10-05

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
78759-001-01	d6a99b39-e285-a426-e053-dadaa90af4c2	5b9a225f-d56d-44ab-a947-8b9ad2bf4565
78759-001-02	d6a99b39-fbd6-a426-e053-dadaa90af4c2	ed2b7305-e669-40d4-b320-c3b41f02c9c2
78759-001-04	d6a99b39-fb80-a426-e053-dadaa90af4c2	2afda290-7547-4d8e-aa5b-7000244d8000
78759-001-08	d6a99b39-fb80-a426-e053-dadaa90af4c2	2afda290-7547-4d8e-aa5b-7000244d8000
78759-001-11	d6a99b39-fb80-a426-e053-dadaa90af4c2	2afda290-7547-4d8e-aa5b-7000244d8000
78759-001-16	d6a99b39-b031-a426-e053-dadaa90af4c2	ad6d48bd-8cbe-4466-bef1-70c1b075a257
78759-001-32	d6a99b39-c934-a426-e053-dadaa90af4c2	a4f0eafc-347a-489a-86d4-e51dfc0f261a
78759-001-55	d6a99b39-e282-a426-e053-dadaa90af4c2	9204086c-ec3f-49c8-b112-8ef3cf1481f1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78759-001-04	PHM Safe	.118 L in 1 BOTTLE, PLASTIC	SOLUTION	.118	2
78759-001-08	PHM Safe	.236 L in 1 BOTTLE, PLASTIC	SOLUTION	.236	2
78759-001-11	PHM Safe	.060 L in 1 BOTTLE, PLASTIC	SOLUTION	.060	2
78759-001-01	PHM Safe	3.785 L in 1 BOTTLE, PLASTIC	SOLUTION	3.785	1
78759-001-02	PHM Safe	.06 L in 1 BOTTLE, PLASTIC	SOLUTION	.06	1
78759-001-16	PHM Safe	.473 L in 1 BOTTLE, PLASTIC	SOLUTION	.473	1
78759-001-32	PHM Safe	.946 L in 1 BOTTLE, PLASTIC	SOLUTION	.946	1
78759-001-55	PHM Safe	208 L in 1 BOTTLE, PLASTIC	SOLUTION	208	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78759-001	PHM SAFE (ALCOHOL) SOLUTION [PHM BRANDS, LLC]	2	Legacy NDC, 3 package rows	20200917_2afda290-7547-4d8e-aa5b-7000244d8000.zip
78759-001	PHM SAFE (ALCOHOL) SOLUTION [PHM BRANDS, LLC]	1	Legacy NDC, 1 package rows	20200914_ad6d48bd-8cbe-4466-bef1-70c1b075a257.zip
78759-001	PHM SAFE (ALCOHOL) SOLUTION [PHM BRANDS, LLC]	1	Legacy NDC, 1 package rows	20200914_9204086c-ec3f-49c8-b112-8ef3cf1481f1.zip
78759-001	PHM SAFE (ALCOHOL) SOLUTION [PHM BRANDS, LLC]	1	Legacy NDC, 1 package rows	20200914_ed2b7305-e669-40d4-b320-c3b41f02c9c2.zip
78759-001	PHM SAFE (ALCOHOL) SOLUTION [PHM BRANDS, LLC]	1	Legacy NDC, 1 package rows	20200905_5b9a225f-d56d-44ab-a947-8b9ad2bf4565.zip
78759-001	PHM SAFE (ALCOHOL) SOLUTION [PHM BRANDS, LLC]	1	Legacy NDC, 1 package rows	20200914_a4f0eafc-347a-489a-86d4-e51dfc0f261a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039339	ethanol 80 % Topical Solution	PSN	2afda290-7547-4d8e-aa5b-7000244d8000	2
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	2afda290-7547-4d8e-aa5b-7000244d8000	2
1039339	ethanol 80 % Topical Solution	SY	2afda290-7547-4d8e-aa5b-7000244d8000	2
1039339	ethanol 80 % Topical Solution	PSN	ed2b7305-e669-40d4-b320-c3b41f02c9c2	1
1039339	ethanol 80 % Topical Solution	PSN	5b9a225f-d56d-44ab-a947-8b9ad2bf4565	1
1039339	ethanol 80 % Topical Solution	PSN	9204086c-ec3f-49c8-b112-8ef3cf1481f1	1
1039339	ethanol 80 % Topical Solution	PSN	ad6d48bd-8cbe-4466-bef1-70c1b075a257	1
1039339	ethanol 80 % Topical Solution	PSN	a4f0eafc-347a-489a-86d4-e51dfc0f261a	1
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	a4f0eafc-347a-489a-86d4-e51dfc0f261a	1
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	ed2b7305-e669-40d4-b320-c3b41f02c9c2	1
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	ad6d48bd-8cbe-4466-bef1-70c1b075a257	1
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	9204086c-ec3f-49c8-b112-8ef3cf1481f1	1
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	5b9a225f-d56d-44ab-a947-8b9ad2bf4565	1
1039339	ethanol 80 % Topical Solution	SY	a4f0eafc-347a-489a-86d4-e51dfc0f261a	1
1039339	ethanol 80 % Topical Solution	SY	ad6d48bd-8cbe-4466-bef1-70c1b075a257	1
1039339	ethanol 80 % Topical Solution	SY	9204086c-ec3f-49c8-b112-8ef3cf1481f1	1
1039339	ethanol 80 % Topical Solution	SY	5b9a225f-d56d-44ab-a947-8b9ad2bf4565	1
1039339	ethanol 80 % Topical Solution	SY	ed2b7305-e669-40d4-b320-c3b41f02c9c2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
78759-001-04	78759000104	.118 L in 1 BOTTLE, PLASTIC (78759-001-04)	2020-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHM Safe - PHM Brands, LLC \| Viobin, LLC	PHM Brands, LLC \| Viobin, LLC	2020-09-14	HUMAN OTC DRUG LABEL	1
PHM Safe - PHM Brands, LLC \| Viobin, LLC	PHM Brands, LLC \| Viobin, LLC	2020-09-14	HUMAN OTC DRUG LABEL	1
PHM Safe - PHM Brands, LLC \| Viobin, LLC	PHM Brands, LLC \| Viobin, LLC	2020-09-14	HUMAN OTC DRUG LABEL	1
PHM Safe - PHM Brands, LLC \| Viobin, LLC	PHM Brands, LLC \| Viobin, LLC	2020-09-14	HUMAN OTC DRUG LABEL	1
PHM Safe - PHM Brands, LLC \| Viobin, LLC	PHM Brands, LLC \| Viobin, LLC	2020-09-14	HUMAN OTC DRUG LABEL	1
PHM Safe - PHM Brands, LLC \| Viobin, LLC	PHM Brands, LLC \| Viobin, LLC	2020-09-10	HUMAN OTC DRUG LABEL	2