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 41 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	Wal-Mart Stores, Inc.	750e0355-369e-b679-e053-2a91aa0a66ca	2023-11-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Wal-Mart Stores, Inc.	750efd58-5845-fbc4-e053-2a91aa0a86d1	2023-11-01	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	WALGREEN COMPANY	ba4a29b3-2ddc-b906-e053-2995a90a2ab7	2023-11-01	Warnings	Exact identifier application number: M007
DOCUZEN	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Proficient Rx LP	92879e62-f60a-4ab4-9532-610cdd2628ee	2023-11-01	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	A-S Medication Solutions	5999904a-6ac8-4d9e-951c-6e64e8cd93eb	2023-11-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e98f9d9-679c-63a2-e053-2991aa0a4b8d	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e957b01-4f44-0a2a-e053-2991aa0a37a0	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e993b13-8dc8-6653-e053-2a91aa0a4c2a	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	CVS	3c8e4144-6702-2678-e054-00144ff88e88	2023-10-31	Warnings	Exact identifier application number: M007
Fiber Laxative	CALCIUM POLYCARBOPHIL	Magno-Humphries, Inc.	9d22c208-d089-8b6a-e053-2995a90ab90a	2023-10-27	Warnings	Exact identifier application number: M007
Stool Softener Docusate Sodium	DOCUSATE SODIUM	Magno-Humphries, Inc.	a0e6ab9b-fd31-45fd-93d5-b51d705c180a	2023-10-27	Warnings	Exact identifier application number: M007
Sennosides Natural Laxative	SENNOSIDES	Magno-Humphries, Inc.	9d22bedb-9fca-8421-e053-2a95a90acf4a	2023-10-27	Warnings	Exact identifier application number: M007
Stool Softener Docusate Sodium	DOCUSATE SODIUM	Magno-Humphries, Inc.	9d22d642-8aed-d17e-e053-2995a90ae182	2023-10-27	Warnings	Exact identifier application number: M007
Senna S	DOCUSATE SODIUM, SENNOSIDES	Magno-Humphries, Inc.	9deaf264-6af0-40ba-e053-2a95a90ada0e	2023-10-27	Warnings	Exact identifier application number: M007
FLEET	MINERAL OIL	C.B. Fleet Company, Inc.	2528cb5e-437e-41f0-9c34-e9ce57404d8b	2023-10-26	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Major Pharmaceuticals	088e5543-c947-af78-e063-6294a90a8bc4	2023-10-25	Warnings	Exact identifier application number: M007
DOK	DOCUSATE SODIUM	MAJOR PHARMACEUTICALS	7a92070d-98cc-662f-e053-2991aa0aa1b2	2023-10-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	KROGER COMPANY	a1afaa71-7e8c-5a49-e053-2a95a90a4db0	2023-10-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Geri-Care Pharmaceutical Corp	644d81ec-d38f-4172-a087-727b94e2fefe	2023-10-19	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Asclemed USA, Inc.	30fc8c07-c26b-4bcc-a727-6e193f5727fd	2023-10-16	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