Mineral Oil

Product NDC: 21130-831
Requested package NDC: 21130-831-43
11-digit product format: 211300831
Labeler code: 21130
Product ID: 21130-831_4b92e29d-b8ec-ed74-e063-6294a90ae2f4
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral Oil
Dosage form: LIQUID
Route: ORAL; TOPICAL
Labeler: Better Living Brands, LLC
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2002-11-13
Substance: MINERAL OIL
Active strength: 999 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mineral Oil
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINERAL OIL	999 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
705909	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
7f2f1b30-497a-4c53-accc-8455169b17b3	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21130-831-43	2024-04-18	C162847	48780-1	d6a99b39-73c7-a426-e053-dadaa90af4c2	Signature Care 831.000/831AA Mineral Oil
21130-831-43	2022-01-28	C162847	48780-1	d6a99b39-73c7-a426-e053-dadaa90af4c2	Signature Care 831.000/831AA Mineral Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-831-43	Mineral Oil	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	MINERAL OIL LIQUID [SAFEWAY]	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	MINERAL OIL LIQUID [SAFEWAY]	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	MINERAL OIL LIQUID [SAFEWAY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-831	MINERAL OIL LIQUID [BETTER LIVING BRANDS LLC]	9	Current NDC, Legacy NDC, 1 package rows	20250406_7f2f1b30-497a-4c53-accc-8455169b17b3.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 1 of 44 · 873 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Health Childrens Saline Laxative	MAGNESIUM HYDROXIDE	CVS PHARMACY,INC.	e57e5529-2190-4c66-8397-bc2848739e59	2026-08-14	Warnings	Exact identifier application number: M007
Docusate Sodium and Sennosides	DOCUSATE SODIUM AND SENNOSIDES	Morepen Bio Inc	562d1b9a-09d8-92fc-e063-6394a90a1993	2026-08-14	Warnings	Exact identifier application number: M007
CVS Health	NATURAL FIBER SUPPLEMENT	CVS Pharmacy,Inc.	04dbe9aa-ed18-4d76-a840-d010445a8643	2026-08-14	Warnings	Exact identifier application number: M007
CVS Fiber Therapy	METHYLCELLULOSE	CVS PHARMACY	e066f5bd-5f34-4e04-beec-3c7d6db49381	2026-08-13	Warnings	Exact identifier application number: M007
Mineral oil	MINERAL OIL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	92f2147d-b52d-4282-b217-28f6095dca0e	2026-08-12	Warnings	Exact identifier application number: M007
CAREONE Orange Flavored	PSYLLIUM HUSK	FOODHOLD USA	4b1cccd2-e941-4d51-9924-4ca35e3a4429	2026-08-11	Warnings	Exact identifier application number: M007
CAREONE	PSYLLIUM HUSK	FOODHOLD USA	3ec3ead0-382e-4765-bbe8-b21e7c7b42a6	2026-08-11	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f4671579-aed0-4f93-ab83-248e0d72b5b0	2026-08-10	Warnings	Exact identifier application number: M007
Docusate Sodium Liquid	DOCUSATE SODIUM.50MG/5ML	Aldama Pharmaceuticals, Inc	492b6d37-47cf-3a28-e063-6294a90a2a18	2026-08-10	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Safeway Inc	0b757160-f9eb-4413-9b43-97544c49c72f	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M007
Senna S	DOCUSATE SODIUM, SENNOSIDES	Shield Pharmaceuticals Corp	0be906d8-3db5-4218-bbdf-f1d126007990	2026-08-07	Warnings	Exact identifier application number: M007
MiraFAST KIDS soft chews	MAGNESIUM HYDROXIDE	Bayer HealthCare LLC.	58636827-239d-cc63-e063-6294a90a6180	2026-08-06	Warnings	Exact identifier application number: M007
Stool Softener Extra Strength	DOCUSATE SODIUM	P & L Development, LLC	4e97dd60-96e3-4b51-b614-c62480af1919	2026-08-06	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	P & L Development, LLC	098d2377-0019-45fe-b995-700b1b1241c4	2026-08-05	Warnings	Exact identifier application number: M007
Docusate Sodium softgels 50mg (Dye Free)	DOCUSATE SODIUM	CVS Pharmacy	273ea95f-3c9c-98e8-e063-6294a90a2135	2026-08-05	Warnings	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Old East Main Co.	4bae831d-caba-40c9-bdb5-2611eac35dd5	2026-08-05	Warnings, Adverse reactions	Exact identifier application number: M007
Metamucil Therapy for regularity	PSYLLIUM HUSK	Atlantic Biologicals Corp.	57b112ea-f6b1-baa6-e063-6394a90a3b29	2026-08-05	Warnings	Exact identifier application number: M007
MiraFAST soft chews	MAGNESIUM HYDROXIDE	Bayer HealthCare LLC.	2cee67dd-b71f-32b8-e063-6394a90ae864	2026-08-05	Warnings	Exact identifier application number: M007
MiraSOFT Stool Softener	DOCUSATE SODIUM	Bayer HealthCare LLC.	5851f15f-8add-559f-e063-6394a90a7b7d	2026-08-05	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	P & L Development, LLC	cbb0edf4-1fa7-42f5-a6f7-027e3961b50a	2026-08-05	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
705909	mineral oil 99.9 % Oral Solution	PSN	7f2f1b30-497a-4c53-accc-8455169b17b3	10
705909	mineral oil 999 MG/ML Oral Solution	SCD	7f2f1b30-497a-4c53-accc-8455169b17b3	10
705909	mineral oil 99.9 % Oral Solution	SY	7f2f1b30-497a-4c53-accc-8455169b17b3	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-831-43	21130083143	473 mL in 1 BOTTLE, PLASTIC (21130-831-43)	473 ml	2002-11-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Signature Care 831.000/831AA Mineral Oil	Better Living Brands, LLC \| Nice-Pak Products, LLC	2026-02-24	HUMAN OTC DRUG LABEL	10