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 42 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Extra Strength	DOCUSATE SODIUM	MEIJER, INC.	e43bd2ed-17c7-4530-af72-81a7ad70069c	2023-10-12	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Care One (Retail Business Services, LLC.)	9adaec97-43e3-48f2-96c8-c508b693676c	2023-10-05	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	TopCo Associates, LLC	83aeb90a-ab00-4e26-aa44-5259dce59018	2021-04-28	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	9fbe783e-ddd9-445a-852a-00f4ad754880	2021-04-20	Warnings	Exact identifier application number: M007
Topcare Stool Softener	DOCUSATE SODIUM	TopCo Associates, LLC	6f4fddda-4129-4087-b0e4-ababc5558484	2021-02-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	30c9ff75-cee4-4632-86fd-acfdf5ee85af	2020-10-27	Warnings	Exact identifier application number: M007
Stool Softener	MARC GLASSMAN	Marc Glassman, Inc.	909cd222-d836-416f-aa7d-deb4a0c5a560	2020-09-08	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	Allegiant Health	94a9c24a-07c3-4535-b810-b7abc9fc5ad5	2019-12-11	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Marc Glassman, Inc.	ec34fc1e-d122-4fa4-859e-e89e3e12edd5	2019-09-18	Warnings	Exact identifier application number: M007
Womens Laxative	BISACODYL	Marc Glassman, Inc.	aeb3c49b-cbf5-4a47-b19c-e77fbb987a49	2019-09-17	Warnings	Exact identifier application number: M007
Bisacodyl 5mg	BISACODYL 5MG	Allegiant Health	46a377f5-822b-496f-a73b-66d8f902680a	2019-03-26	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Allegiant Health	51f1c6c0-770c-4426-820b-bc1f42e143fd	2019-02-07	Warnings	Exact identifier application number: M007
Senna-Lax	SENNOSIDES	Marc Glassman, Inc.	7dd97c54-2ba1-4629-87b9-1ba0913fe531	2016-12-27	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