Humco Mineral Oil Heavy

Product NDC: 0395-1685
11-digit product format: 003951685
Labeler code: 0395
Product ID: 0395-1685_0c93390b-bca4-9c43-e063-6294a90aeffb
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral Oil
Dosage form: LIQUID
Route: ORAL
Labeler: Humco Holding Group, Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1998-03-25
Substance: MINERAL OIL
Active strength: 1000 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Humco Mineral Oil Heavy
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINERAL OIL	1000 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T5L8T28FGP	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311714	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
9f943fdf-5058-4e18-ba96-6be112bf72ca	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-1685-28	Humco Mineral Oil Heavy	3800 mL in 1 BOTTLE, PLASTIC	LIQUID	3800		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-1685-28	ML - Milliliter	0395-1685	cfeb10af-aa83-4b74-ace2-c2eecabc965f	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	HUMCO MINERAL OIL HEAVY (MINERAL OIL) LIQUID [HUMCO HOLDING GROUP, INC.]	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	HUMCO MINERAL OIL HEAVY (MINERAL OIL) LIQUID [HUMCO HOLDING GROUP, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	HUMCO MINERAL OIL HEAVY (MINERAL OIL) LIQUID [HUMCO HOLDING GROUP, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-1685	HUMCO MINERAL OIL HEAVY (MINERAL OIL) LIQUID [HUMCO HOLDING GROUP, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20231216_9f943fdf-5058-4e18-ba96-6be112bf72ca.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 8 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Laxomil	BISACODYL 5MG	Pharmadel LLC	3999935b-d8e8-52a6-e063-6294a90aa2a2	2026-03-20	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Grocery Outlet	c820e6a1-fa23-447a-9ee9-50a1bd617adb	2026-03-19	Warnings	Exact identifier application number: M007
CITRUCEL	METHYLCELLULOSE	Haleon US Holdings LLC	9d5f2244-a610-4d45-b6e8-e79bb17a558f	2026-03-18	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Safeway, Inc.	f178b31d-4843-4b91-a0d5-ab5ade835dc2	2026-03-16	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Safeway, Inc.	12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c	2026-03-13	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Old East Main Co.	a1ca668a-3bf9-46a9-8a4f-5cb61547bb81	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Vi-Jon, LLC	b29775df-8470-4fe3-bee3-f0490ea6903f	2026-03-12	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Nice-Pak Products, LLC	cc43d514-ee82-4314-99b2-c64380f98779	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M007
Fibercon	CALCIUM POLYCARBOPHIL	Foundation Consumer Brands	7992a4bb-5535-4a1d-867d-a99f7e0c1be7	2026-03-12	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Walgreens	cda27a9c-9175-4b07-9c0b-d8d897882965	2026-03-12	Warnings	Exact identifier application number: M007
Magnesium Citrate Saline Laxative - Lemon Flavor	MAGNESIUM CITRATE	Universal Distribution Center LLC	aa02c9af-22b8-4ec2-9e43-fe073f5e617b	2026-03-11	Warnings	Exact identifier application number: M007
Magnesium Citrate Saline Laxative - Grape Flavor	MAGNESIUM CITRATE	Universal Distribution Center LLC	021ebb61-2466-4272-8f7d-b49cafd08754	2026-03-11	Warnings	Exact identifier application number: M007
Magnesium Citrate Saline Laxative - Cherry Flavor	MAGNESIUM CITRATE	Universal Distribution Center LLC	1f14411b-6833-40e6-b1a5-2b8c5bf709d3	2026-03-11	Warnings	Exact identifier application number: M007
Citroma	MAGNESIUM CITRATE	UpLift Brands, LLC	f83ba007-734d-4910-87cb-02e45285e161	2026-03-11	Warnings, Adverse reactions	Exact identifier application number: M007
Citroma	MAGNESIUM CITRATE	UpLift Brands, LLC	57e914fa-8fa2-4221-bb5f-534f0ea0aba7	2026-03-11	Warnings, Adverse reactions	Exact identifier application number: M007
Citroma	MAGNESIUM CITRATE	UpLift Brands, LLC	f28a9043-e0ee-4b38-95d9-d3f23d400691	2026-03-11	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Amerisource Bergen	4caf0bcb-c1bf-0ae7-e063-6294a90a344b	2026-03-10	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Walgreens	92df761b-da68-4ce9-b02a-a5a74fd6620e	2026-03-10	Warnings	Exact identifier application number: M007
Fleet	GLYCERIN	C.B. Fleet Company, Inc.	31778652-e60e-4098-8e90-3e4f56b5800c	2026-03-06	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	4c6094b7-c1ef-26a3-e063-6394a90af4cc	2026-03-06	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311714	heavy mineral oil 100 % Oral Solution	PSN	9f943fdf-5058-4e18-ba96-6be112bf72ca	5
311714	heavy mineral oil 1000 MG/ML Oral Solution	SCD	9f943fdf-5058-4e18-ba96-6be112bf72ca	5
311714	heavy mineral oil 100 % Oral Solution	SY	9f943fdf-5058-4e18-ba96-6be112bf72ca	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-1685-28	00395168528	3800 mL in 1 BOTTLE, PLASTIC (0395-1685-28)	3800 ml	2017-11-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Humco Mineral Oil USP Heavy	Humco Holding Group, Inc. \| Pharma Nobis, LLC	2023-12-15	HUMAN OTC DRUG LABEL	5