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: 2027-12-31

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 23 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	H E B	ab995d9a-1e40-2b38-e053-2a95a90a87e4	2025-08-21	Warnings	Exact identifier application number: M007
Senokot	STANDARDIZED SENNA CONCENTRATE	Atlantis Consumer Healthcare, Inc.	d5bf67e5-82c6-edbf-e9ec-e027fdd47c84	2025-08-20	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	330758d2-fc1a-50ce-e063-6294a90a7db1	2025-08-19	Warnings	Exact identifier application number: M007
Sennosides and Docusate Sodium	SENNOSIDES AND DOCUSATE SODIUM	American Health Packaging	4b84d5d7-43cf-47bb-af59-088550c3a0bc	2025-08-12	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Good Sense (Geiss, Destin & Dunn, Inc.)	8066a52d-e683-47c1-905c-290d2d427acf	2025-08-12	Warnings	Exact identifier application number: M007
Prolaxa	DOCUSATE SODIUM 250MG	Advanced Rx of Tennessee, LLC	3ba0c0d9-9e6f-a2e6-e063-6394a90a202d	2025-08-05	Warnings	Exact identifier application number: M007
Dulcolax Stool Softener	DOCUSATE SODIUM	Chattem, Inc.	86cb7102-3585-4757-9c37-5bf9776bbe63	2025-08-01	Warnings	Exact identifier application number: M007
LEADER Mineral Oil	MINERAL OIL	Cardinal Health, 110 dba Leader	7d4f8fa3-8203-5523-e053-2991aa0aba1a	2025-07-28	Warnings	Exact identifier application number: M007
Rapidol Sal Inglesa	MAGNESIUM SULFATE HEPTAHYDRATE	Pharmadel LLC	1d4ef5f0-54c5-4838-e063-6394a90a44a8	2025-07-28	Warnings	Exact identifier application number: M007
Enemeez Kids	DOCUSATE SODIUM	Quest Products LLC	f1602ba4-ad02-2936-e053-2995a90a27f2	2025-07-15	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	Bryant Ranch Prepack	d4ab04e4-b78a-4afc-aa16-d9dc8fb6cc10	2025-07-14	Warnings	Exact identifier application number: M007
Epsom Salt	EPSOM SALT	Strategic Sourcing Services LLC	1515fadd-a7a5-4502-afe2-cfcd50d5bfc8	2025-07-11	Warnings	Exact identifier application number: M007
Quality Choice Fiber Caplets	CALCIUM POLYCARBOPHIL	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	29dbc831-23c1-487d-902a-9404d9ebe805	2025-07-09	Warnings	Exact identifier application number: M007
Rexall Ready to use 4pk LAXATIVE	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Dolgencorp, LLC	78509915-0ef1-4238-99a5-78a49a68f98f	2025-07-07	Warnings	Exact identifier application number: M007
Sal Inglesa EPSOM SALT	MAGNESIUM SULFATE HEPTAHYDRATE	Menper Distributors, Inc	247aa3a3-d38f-4799-b44d-dfe18324fd0c	2025-07-01	Warnings	Exact identifier application number: M007
Stool Softener Extra Strength	DOCUSATE SODIUM	Chain Drug Consortium, LLC	550000ba-0d6d-4666-8461-f591c14478b1	2025-06-27	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Chain Drug Consortium, LLC	c9807e6e-9dcc-41a2-8956-b61623ac2176	2025-06-27	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Chain Drug Consortium, LLC	09449649-fd57-4446-8264-6c3bdd6621d0	2025-06-27	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Bryant Ranch Prepack	f2b14378-2b60-4533-b232-8c8647fbce78	2025-06-26	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	TARGET CORPORATION	28fce2e2-2101-df88-e063-6394a90aa3de	2025-06-25	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