Stye

Product NDC: 63736-238
11-digit product format: 637360238
Labeler code: 63736
Product ID: 63736-238_22a277be-2268-4957-8066-ab2966ecbf93
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral Oil and Petrolatum
Dosage form: GEL
Route: OPHTHALMIC
Labeler: Insight Pharmaceuticals LLC
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-06-15
Substance: MINERAL OIL; PETROLATUM
Active strength: 319; 577 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Stye
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINERAL OIL	319 mg/g
PETROLATUM	577 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T5L8T28FGP	Internal UNII lookup
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
579999	Internal RxNorm lookup
1053146	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
f7eb8466-d8ea-4833-9bed-244ead38a3bf	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63736-238-24	Stye	24 in 1 CASE	GEL	24		5
63736-238-24	Stye	1 in 1 BOX	GEL	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mineral Oil	ACTIVE INGREDIENT	T5L8T28FGP	STYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]	1
Petrolatum	ACTIVE INGREDIENT	4T6H12BN9U	STYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]	1
Mineral Oil	ACTIVE MOIETY	T5L8T28FGP	STYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]	1
Petrolatum	ACTIVE MOIETY	4T6H12BN9U	STYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	STYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]	1
Wheat Germ Oil	INACTIVE INGREDIENT	14C97E680P	STYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63736-238	STYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS LLC]	4	Current NDC, Legacy NDC, 2 package rows	20240104_f7eb8466-d8ea-4833-9bed-244ead38a3bf.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 21 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Discount Drug Mart Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	31a98e6c-42df-6b56-e063-6294a90a3564	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Ultra Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Harris Teeter, LLC.	31ac6883-ffc6-39de-e063-6294a90a52dd	2024-01-01	Warnings	Exact identifier application number: M018
Exchange Select High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Army and Air Force Exchange Service	31ac8bd2-c2e9-6f2c-e063-6394a90adc72	2024-01-01	Warnings	Exact identifier application number: M018
CVS Health Fast Acting Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS Pharmacy, Inc.	31addfd2-52f2-05b3-e063-6294a90a337f	2024-01-01	Warnings	Exact identifier application number: M018
Equate Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Wal-Mart Stores, Inc.	91fb8fb5-b871-4535-e053-2995a90a9b16	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops Preservative-Free	CARBOXYMETHYLCELLULOSE SODIUM	Wal-Mart Stores, Inc.	9228a39b-38d2-1dfc-e053-2a95a90a3c90	2023-12-23	Warnings	Exact identifier application number: M018
Equate Restore Plus Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Walmart, Inc.	9e665ca2-4fa6-fdb4-e053-2a95a90abcca	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Eye Drops Advanced Moisturizer/Lubricant	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE	Strategic Sourcing Services LLC	0daa4e39-0447-44b6-a7d7-370b12bf9451	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Wal-Mart Stores, Inc.	91f85a72-5270-e4db-e053-2995a90aeb21	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Wal-Mart Stores, Inc.	e32233ef-ea15-45b8-8e83-b658cf4c56a0	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Eye Drops Original Formula	TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	33efa7e9-4c3a-4d72-af31-c5e35095c2ff	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Lubricant Eye Drops	POLYPROPYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	b117ff0a-1a48-4022-96e6-52bc45f056fc	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Strategic Sourcing Services LLC	043ccc34-44ee-416a-88bc-f247774e9075	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Lubricating Tears	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	58f0b6d7-6072-40fd-ba72-b3ed68834791	2023-12-23	Warnings	Exact identifier application number: M018
Leader Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Cardinal Health	8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa	2023-12-23	Warnings	Exact identifier application number: M018
Leader Eye Wash	PURIFIED WATER	Cardinal Health	8d3ad11f-1945-f838-e053-2995a90a7aa5	2023-12-23	Warnings	Exact identifier application number: M018
Good Neighbor Pharmacy Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Amerisource Bergen Drug Corp.	fd2dc23f-6ccc-2644-e053-6294a90a889e	2023-12-23	Warnings	Exact identifier application number: M018
Rite Aid Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Rite Aid Corporation	fa1b5b66-9643-e9a7-e053-6394a90ae3cf	2023-12-23	Warnings	Exact identifier application number: M018
Signature Care Lubricant Eye Drops Long Lasting	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Better Living Brands, LLC	05a63929-fccd-2936-e063-6294a90aeac5	2023-12-23	Warnings	Exact identifier application number: M018
Meijer Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Meijer Distribution, Inc.	9feadde4-fbe5-0c9e-e053-2995a90a9b30	2023-12-22	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
579999	mineral oil 31.9 % / petrolatum 57.7 % Ophthalmic Ointment	PSN	f7eb8466-d8ea-4833-9bed-244ead38a3bf	5
1053146	Stye 31.9 % / 57.7 % Ophthalmic Ointment	PSN	f7eb8466-d8ea-4833-9bed-244ead38a3bf	5
1053146	mineral oil 0.319 MG/MG / petrolatum 0.577 MG/MG Ophthalmic Ointment [Stye]	SBD	f7eb8466-d8ea-4833-9bed-244ead38a3bf	5
579999	mineral oil 0.319 MG/MG / petrolatum 0.577 MG/MG Ophthalmic Ointment	SCD	f7eb8466-d8ea-4833-9bed-244ead38a3bf	5
579999	mineral oil 31.9 % / petrolatum, white 57.7 % Ophthalmic Ointment	SY	f7eb8466-d8ea-4833-9bed-244ead38a3bf	5
1053146	Stye (mineral Oil 0.319 MG/MG / petrolatum, white 0.577 MG/MG) Ophthalmic Ointment	SY	f7eb8466-d8ea-4833-9bed-244ead38a3bf	5
1053146	Stye (mineral oil 31.9 % / petrolatum, white 57.7 % ) Ophthalmic Ointment	SY	f7eb8466-d8ea-4833-9bed-244ead38a3bf	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63736-238-24	63736023824	24 BOX in 1 CASE (63736-238-24) / 1 TUBE in 1 BOX / 3.5 g in 1 TUBE	24 box	2010-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Stye	Insight Pharmaceuticals LLC	2025-08-11	HUMAN OTC DRUG LABEL	5
Model AA-1218CEV	Aerospace Accessory Service, Inc	2021-05-05	MEDICAL DEVICE	2