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 15 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Gentle Laxative	BISACODYL	CVS Pharmacy	0cca1516-fc8d-4471-bd37-a6230fd225e2	2026-01-14	Warnings	Exact identifier application number: M007
Rite-Aid Gentle Laxative	BISACODYL	RITE AID PHARMACY	0fb853db-8d97-64d6-e063-6294a90abeb5	2026-01-14	Warnings	Exact identifier application number: M007
Rite-Aid Glycerin Laxative	GLYCERIN SUPPOSITORY	RITE AID CORPORATION	0fb8f488-3386-29b9-e063-6294a90a014c	2026-01-14	Warnings	Exact identifier application number: M007
Rite-Aid Childrens Glycerin Laxative	GLYCERIN SUPPOSITORY	RITE AID CORPORATION	0fbe4dfd-1d5d-fc31-e063-6394a90ab317	2026-01-14	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	TOP CARE (Topco Associates LLC)	92659389-c36f-499b-b284-5b520e50e9a6	2026-01-14	Warnings	Exact identifier application number: M007
Senna Syrup	SENNOSIDES	AVPAK	af75d33f-b081-4b9d-bc12-d2829fa1f0cf	2026-01-09	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Care One (Retail Business Services, LLC.)	597d2e9c-1adb-4c7d-ada3-de5c2db69c74	2026-01-09	Warnings	Exact identifier application number: M007
Foster and Thrive Ready to Use Mineral oil Laxative	MINERAL OIL	Strategic Sourcing Services LLC	ea6da66c-6825-4cd7-8791-45b537bf203a	2026-01-08	Warnings	Exact identifier application number: M007
Sunmark Saline Single Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Strategic Sourcing Services LLC	06720229-7d58-499e-b7de-cb4bda5ae416	2026-01-08	Warnings	Exact identifier application number: M007
HealthMart Mineral Oil Single Laxative	MINERAL OIL	Strategic Sourcing Services LLC	1238ec69-1ea3-4773-9f13-71f0ae0a3553	2026-01-08	Warnings	Exact identifier application number: M007
HealthMart Saline Single Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Strategic Sourcing Services LLC	689228de-1f3e-4205-853d-6004d6248857	2026-01-08	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	c445864f-fc88-4885-9f40-d189b9dc4290	2026-01-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	c46a1f7c-12e3-4be1-b9e4-d3edac0f4386	2026-01-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	TOP CARE (Topco Associates LLC)	44fe6ce0-5fed-418f-8a6a-d6132e288328	2026-01-07	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Strategic Sourcing Services LLC	24e29f00-f1cf-4e92-bd67-3f6f820af783	2026-01-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	P & L Development, LLC	33000a06-e030-433a-8f9c-7ae5c08037fa	2026-01-06	Warnings	Exact identifier application number: M007
Stool Softener Regular Strength	DOCUSATE SODIUM	Sam's West, Inc	1eca5910-b0bf-4e07-8211-36dba52b3de7	2026-01-06	Warnings	Exact identifier application number: M007
Milk of Magnesia	MAGNESIUM HYDROXIDE	Major Pharmaceuticals	c3d14605-fdec-49fc-b0ee-d4c3ae5f42b5	2026-01-05	Warnings	Exact identifier application number: M007
GeriCare Sorbitol Solution	SORBITOL	GERI-CARE PHARMACEUTICALS, CORP	b4dd7a41-380e-d94b-e053-2a95a90ac34a	2025-12-31	Warnings	Exact identifier application number: M007
Docusate Sodium Liquid	DOCUSATE SODIUM	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c	2025-12-31	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