Sunmark Mineral Oil

Product NDC: 49348-185
11-digit product format: 493480185
Labeler code: 49348
Product ID: 49348-185_fdbfcdfe-c67a-4aa5-9dc5-f4bd11a51a53
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral Oil
Dosage form: ENEMA
Route: RECTAL
Labeler: Strategic Sourcing Services
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2002-11-13
Substance: MINERAL OIL
Active strength: 118 g/118mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	49348-185		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-185	49348-185-20	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: Sunmark Mineral Oil
Brand name suffix: Laxative
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINERAL OIL	118 g/118mL

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
205121	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
c54f7df2-3845-425f-b13e-3dc000123f3c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-185-20	Sunmark Mineral OilLaxative	1 in 1 CARTON	ENEMA	1		5
49348-185-20	Sunmark Mineral OilLaxative	133 mL in 1 BOTTLE	ENEMA	133		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-185-20	ML - Milliliter	49348-185	dbbce4c4-e389-4c66-a02b-e754431205a3	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-185	SUNMARK MINERAL OIL LAXATIVE (MINERAL OIL) ENEMA [STRATEGIC SOURCING SERVICES]	5	Current NDC, Legacy NDC, 2 package rows	20250117_c54f7df2-3845-425f-b13e-3dc000123f3c.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 24 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fleet	BISACODYL	C.B. Fleet Company, Inc.	324e61eb-8f6b-48d7-85c2-b1b5642691c9	2025-06-23	Warnings	Exact identifier application number: M007
Saline Laxative	SODIUM PHOSPHATE	Walgreen Company	fb260df0-7bda-4299-84a5-44c8f9447798	2025-06-18	Warnings	Exact identifier application number: M007
De La Cruz Castor Oil	CASTOR OIL	DLC Laboratories, Inc.	22fbad2e-e9fa-46ba-8617-ad79483cbe9a	2025-06-13	Warnings	Exact identifier application number: M007
Prolaxa	DOCUSATE SODIUM 250MG	Terrain Pharmaceuticals	32610e42-f352-09fd-e063-6394a90abff6	2025-06-12	Warnings	Exact identifier application number: M007
DOCUZEN	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Village Pharma	29102014-9b0e-4899-958d-83111f94a612	2025-06-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Power Health, Products, Inc.	364b558b-69b5-bfa4-e063-6294a90acd0c	2025-05-29	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Power Health, Products, Inc.	364bc4f5-6337-6c89-e063-6394a90a12ab	2025-05-29	Warnings	Exact identifier application number: M007
SENNA	SENNOSIDES	AARNA USA INC.	364d4dfc-a089-1a27-e063-6394a90ad77b	2025-05-29	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA CHERRY	MAGNESIUM HYDROXIDE	Power Health, Products, Inc.	3634b4e4-4fea-9428-e063-6394a90a6ad9	2025-05-28	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA ORIGINAL	MAGNESIUM HYDROXIDE	ATLANTIC BIOLOGICALS CORP.	30fb7b5e-56a3-423e-ae57-432006b54fff	2025-05-23	Warnings	Exact identifier application number: M007
Senna Liquid	SENNA LIQUID	Belleview Biosciences	35d5f217-b101-3cd8-e063-6394a90adccd	2025-05-23	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Walgreens	816c82f8-0fa5-4b22-a226-e8f22f3eaa1d	2025-05-23	Warnings	Exact identifier application number: M007
Senna Laxative	SENNA	PD-Rx Pharmaceuticals, Inc.	2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa	2025-05-21	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Akron Pharma Inc.	55ce3969-d7a6-49c4-8c13-d95690efc1a6	2025-05-16	Warnings	Exact identifier application number: M007
Saline Enema	SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC	Dynarex Corporation	7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5	2025-05-14	Warnings	Exact identifier application number: M007
Bisacodyl	BISACODYL	Rising Pharma Holdings, Inc.	03429da4-1ce9-4789-bf54-ce1b3215b013	2025-05-13	Warnings	Exact identifier application number: M007
COLACE EXTRA STRENGTH STOOL SOFTNER	DOCUSATE SODIUM	Atlantis Consumer Healthcare Inc.	34e06b05-64a5-4b3e-af38-cdcd7c1d521b	2025-05-01	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	PAI Holdings, LLC dba PAI Pharma	7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed	2025-04-28	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Belleview Bio Science	335f41d7-5c22-7c17-e063-6294a90a8f28	2025-04-22	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	American Health Packaging	e5028f6d-d33d-47a9-8453-00af5cdf59a6	2025-04-20	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
205121	mineral oil 100 % Enema	PSN	c54f7df2-3845-425f-b13e-3dc000123f3c	5
205121	mineral oil 1000 MG/ML Enema	SCD	c54f7df2-3845-425f-b13e-3dc000123f3c	5
205121	mineral oil 100 % Enema	SY	c54f7df2-3845-425f-b13e-3dc000123f3c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-185-20	49348018520	1 BOTTLE in 1 CARTON (49348-185-20) / 133 mL in 1 BOTTLE	1 bottle	2002-11-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunmark ® Mineral Oil Enema Laxative	Strategic Sourcing Services \| Natureplex LLC	2025-01-14	HUMAN OTC DRUG LABEL	5