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 16 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna-S	DOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MG	Walgreens	36cc3a5b-1891-d39e-e063-6294a90a93b4	2025-12-31	Warnings	Exact identifier application number: M007
Senna Liquid	SENNOSIDES	RUGBY LABORATORIES	8123b092-2ae9-459b-ae06-6ceb837adcf8	2025-12-30	Warnings	Exact identifier application number: M007
Docusate Sodium Liquid	DOCUSATE SODIUM	RUGBY LABORATORIES	e21d19d8-6c2d-4474-a663-dfe7e91ac320	2025-12-30	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	RUGBY LABORATORIES	b1bafa6e-0f54-1c35-e053-2995a90a42e4	2025-12-30	Warnings	Exact identifier application number: M007
OneLAX SENNA	SENNA	ATLANTIC BIOLOGICALS CORP.	d2a5a13a-e7e4-488a-b60b-4dd467efa971	2025-12-29	Warnings	Exact identifier application number: M007
Senna Syrup	SENNOSIDES	Llorens Pharmaceutical International Division, Inc.	5be0163c-b7f7-46db-b738-78c2946a6cf6	2025-12-29	Warnings	Exact identifier application number: M007
Senokot	STANDARDIZED SENNA CONCENTRATE	Atlantis Consumer Healthcare, Inc.	c18dd7fa-993b-440b-8cdd-f1551abb99ca	2025-12-29	Warnings	Exact identifier application number: M007
LAXATIVE	BISACODYL	GRAXCELL PHARMACEUTICAL, LLC	5a65d4ab-447f-42bb-b38d-070db523b806	2025-12-25	Warnings	Exact identifier application number: M007
Senna-S	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Pharbest Pharmaceuticals, Inc.	2b5152b2-d354-409f-a19f-b470f4181b3f	2025-12-24	Warnings	Exact identifier application number: M007
Senna Tabs	SENNA	Pharbest Pharmaceuticals, Inc.	b9f8ea59-932f-4827-a87c-b4aff909c43f	2025-12-24	Warnings	Exact identifier application number: M007
Senna Plus	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	CARDINAL HEALTH, 110 DBA LEADER	4d4101ca-7d78-4712-9b3d-f395f2646c6b	2025-12-23	Warnings	Exact identifier application number: M007
Equate Gentle Laxative Soft chew	MAGNESIUM HYDROXIDE	Walmart	0997c1b7-16db-7db7-e063-6294a90a5928	2025-12-23	Warnings	Exact identifier application number: M007
Equate Kids Gentle Laxative SC	MAGNESIUM HYDROXIDE	Walmart	1662a542-aef0-9087-e063-6294a90aa6d9	2025-12-23	Warnings	Exact identifier application number: M007
AMAZON FIBER CAPLETS	CALCIUM POLYCARBOPHIL	AMAZON.COM SERVICES LLC	178f4150-c75c-45e1-a5f3-3af67b5c8109	2025-12-22	Warnings	Exact identifier application number: M007
AMAZON FIBER THERAPY	METHYLCELLULOSE	AMAZON.COM SERVICES LLC	3eee7b21-5401-4ef1-b1c6-1013439639d2	2025-12-22	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	Granules USA Inc	a619b8f4-1b5d-181b-e053-2995a90ab729	2025-12-22	Warnings	Exact identifier application number: M007
CAREALL Sennosides	SENNOSIDES	New World Imports, Inc	61bbbb6a-9997-4df1-94be-a80686d1f1b9	2025-12-22	Warnings	Exact identifier application number: M007
Walgreens Blueberry Raspberry Gentle Laxative	MAGNESIUM HYDROXIDE	Walgreen	d35f1518-bc63-83eb-e053-2995a90ae4bb	2025-12-21	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	Walgreens Co	85a2f7ed-315e-2403-e053-2991aa0abdce	2025-12-19	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	H E B	a5652d5b-43fd-5bfa-e053-2995a90aad6c	2025-12-19	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