International Harbor

Product NDC: 79838-003
11-digit product format: 798380003
Labeler code: 79838
Product ID: 79838-003_afdd25ba-fe03-31e9-e053-2a95a90a2c99
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: INTERNATIONAL HARBOR LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-30
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 75 mL/100mL
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	79838-003		I	Inactivated by FDA	2026-07-31
excluded package	package	79838-003	79838-003-01	I	Inactivated by FDA	2026-07-31
excluded package	package	79838-003	79838-003-02	I	Inactivated by FDA	2026-07-31
excluded package	package	79838-003	79838-003-03	I	Inactivated by FDA	2026-07-31
excluded package	package	79838-003	79838-003-04	I	Inactivated by FDA	2026-07-31
excluded package	package	79838-003	79838-003-05	I	Inactivated by FDA	2026-07-31
excluded package	package	79838-003	79838-003-06	I	Inactivated by FDA	2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mist	ALCOHOL	Derma Glove	4513f6b9-ceac-415d-a1af-1f7585c5989e	2025-11-14	Warnings	Exact identifier
Hand Recovery	ALCOHOL	Derma Glove	90058ba8-e55d-4318-9fc5-8f0d25dfdd99	2025-11-14	Warnings	Exact identifier
KONIX Alcohol Antiseptic Hand Rub	KONIX ALCOHOL ANTISEPTIC HAND RUB	TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS	17435b35-815b-4292-a809-e533ea137b80	2025-01-29	Warnings	Exact identifier
Hand Recovery	ALCOHOL	Derma Glove	074a760f-9031-40c1-9867-95ef0345418d	2025-01-08	Warnings	Exact identifier
Mist	ALCOHOL	Derma Glove	2a0bcc4e-5114-4afc-91cb-cb4816a63db2	2024-10-09	Warnings	Exact identifier
Hand	LOTION	Derma Glove	ba9611a3-e2a4-4835-9ffe-aafe85a7cb9c	2024-10-09	Warnings	Exact identifier
Hand Relief	LOTION	Derma Glove	45d130c9-0835-45bb-b525-86a2119c87d1	2024-10-09	Warnings	Exact identifier
Mist	ALCOHOL	Derma Glove	b5bfd7f0-0f96-459e-84d4-24b2081ae46f	2024-10-09	Warnings	Exact identifier
Hand Relief	LOTION	Derma Glove	e2f89d56-5624-4a94-8151-1edb508232ac	2024-10-09	Warnings	Exact identifier
Hand Recovery	ALCOHOL	Derma Glove	06f74478-57aa-4b8d-b888-55e1ee4fbd45	2024-10-09	Warnings	Exact identifier
Hand Relief	LOTION	Derma Glove	d3926f48-3a42-42df-a850-47b3914ba3b6	2024-10-09	Warnings	Exact identifier
Mist	ALCOHOL	Derma Glove	7c21ee1c-ce2a-464b-8269-cdb3e59db094	2024-10-09	Warnings	Exact identifier
Hand	LOTION	Derma Glove	bcd71f37-63aa-4ad9-a9be-e5519c7e66e7	2024-10-09	Warnings	Exact identifier
Hand Relief	LOTION	Derma Glove	ffdfb167-0efa-4cd8-afdf-e1ff69ee6252	2024-10-09	Warnings	Exact identifier
Mist	ALCOHOL	Derma Glove	11c2939c-e77a-48f6-949c-9d508714012b	2024-10-09	Warnings	Exact identifier
Hand Recovery	ALCOHOL	Derma Glove	e6cfe092-cb2c-441b-8897-98626c43bef8	2024-10-09	Warnings	Exact identifier
Hand	LOTION	Derma Glove	642cc56f-9f39-46be-bbd8-a2346a0efac4	2024-10-09	Warnings	Exact identifier
Hand	LOTION	Derma Glove	93736944-7535-4035-93aa-4771138af8e3	2024-10-09	Warnings	Exact identifier
Hand Relief	LOTION	Derma Glove	39867f66-b641-4060-881d-161c2591d19c	2024-10-09	Warnings	Exact identifier
Hand Relief	LOTION	Derma Glove	767cc1f2-89a2-4d0b-ae49-ad7b9afca18b	2024-10-09	Warnings	Exact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Flammable. Keep away from children.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79838-003-01	2021-07-23	C162847	48780-1	c7ccaba7-14f7-fd44-e053-dadaa90aa01b	International Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-02	2021-07-23	C162847	48780-1	c7ccaba7-14f7-fd44-e053-dadaa90aa01b	International Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-03	2021-07-23	C162847	48780-1	c7ccaba7-14f7-fd44-e053-dadaa90aa01b	International Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-04	2021-07-23	C162847	48780-1	c7ccaba7-14f7-fd44-e053-dadaa90aa01b	International Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-05	2021-07-23	C162847	48780-1	c7ccaba7-14f7-fd44-e053-dadaa90aa01b	International Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-06	2021-07-23	C162847	48780-1	c7ccaba7-14f7-fd44-e053-dadaa90aa01b	International Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
79838-003-01	International Harbor	60 mL in 1 BOTTLE	GEL	60	1
79838-003-02	International Harbor	250 mL in 1 BOTTLE	GEL	250	1
79838-003-03	International Harbor	500 mL in 1 BOTTLE	GEL	500	1
79838-003-04	International Harbor	1000 mL in 1 BOTTLE	GEL	1000	1
79838-003-05	International Harbor	1800 mL in 1 BOTTLE	GEL	1800	1
79838-003-06	International Harbor	3785 mL in 1 BOTTLE	GEL	3785	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79838-003	INTERNATIONAL HARBOR (ALCOHOL) GEL [INTERNATIONAL HARBOR LLC]	1	Legacy NDC, 6 package rows	20200923_afdd2516-7405-c93c-e053-2995a90a8646.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
1305100	ethanol 75 % Topical Gel	PSN	afdd2516-7405-c93c-e053-2995a90a8646	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	afdd2516-7405-c93c-e053-2995a90a8646	1
1305100	ethanol 75 % Topical Gel	SY	afdd2516-7405-c93c-e053-2995a90a8646	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79838-003-01	79838000301	60 mL in 1 BOTTLE (79838-003-01)	60 ml	2020-03-30	0000-00-00	No	No	Current
79838-003-02	79838000302	250 mL in 1 BOTTLE (79838-003-02)	250 ml	2020-03-30	0000-00-00	No	No	Current
79838-003-03	79838000303	500 mL in 1 BOTTLE (79838-003-03)	500 ml	2020-03-30	0000-00-00	No	No	Current
79838-003-04	79838000304	1000 mL in 1 BOTTLE (79838-003-04)	1000 ml	2020-03-30	0000-00-00	No	No	Current
79838-003-05	79838000305	1800 mL in 1 BOTTLE (79838-003-05)	1800 ml	2020-03-30	0000-00-00	No	No	Current
79838-003-06	79838000306	3785 mL in 1 BOTTLE (79838-003-06)	3785 ml	2020-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
International Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)	INTERNATIONAL HARBOR LLC \| Octapod, S.A. de C.V.	2020-09-21	HUMAN OTC DRUG LABEL	1