Tears Again

Product NDC: 54799-906
Requested package NDC: 54799-906-35
11-digit product format: 547990906
Labeler code: 54799
Product ID: 54799-906_8326ab83-6524-429b-8ae0-3057cb66aede
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral oil, White petrolatum
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: OCuSOFT, Inc.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-09-01
Marketing end: 0000-00-00
Substance: MINERAL OIL; PETROLATUM
Active strength: 200 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	54799-906	54799-906-35	D	Discontinued by firm		2026-11-10

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 · 12 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
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54799-906-35	GM - Gram	54799-906	007c06b1-4823-42f0-9d0b-56b20798db42	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mineral Oil	ACTIVE INGREDIENT	T5L8T28FGP	TEARS AGAIN OPHT (MINERAL OIL, WHITE PETROLATUM) OINTMENT [OCUSOFT, INC.]	1
Petrolatum	ACTIVE INGREDIENT	4T6H12BN9U	TEARS AGAIN OPHT (MINERAL OIL, WHITE PETROLATUM) OINTMENT [OCUSOFT, INC.]	1
Mineral Oil	ACTIVE MOIETY	T5L8T28FGP	TEARS AGAIN OPHT (MINERAL OIL, WHITE PETROLATUM) OINTMENT [OCUSOFT, INC.]	1
Petrolatum	ACTIVE MOIETY	4T6H12BN9U	TEARS AGAIN OPHT (MINERAL OIL, WHITE PETROLATUM) OINTMENT [OCUSOFT, INC.]	1

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54799-906-35	54799090635	5 g in 1 TUBE (54799-906-35)	5 g	2013-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tears Again Eye Ointment	OCuSOFT, Inc. \| Galentic Pharma (India) Private Limited	2019-03-01	HUMAN OTC DRUG LABEL	3