Sunmark Hemorrhoidal

Product NDC: 49348-198
11-digit product format: 493480198
Labeler code: 49348
Product ID: 49348-198_4b42d6cd-f4cd-439d-b9ee-8750abb322ab
Type: HUMAN OTC DRUG
Nonproprietary name: mineral oil, petrolatum, phenylephrine HCl
Dosage form: OINTMENT
Route: RECTAL
Labeler: Strategic Sourcing Services LLC
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-07-25
Marketing end: 0000-00-00
Substance: MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 14 g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49348-198		D	Discontinued by firm		2026-10-15
excluded package	package	49348-198	49348-198-78	D	Discontinued by firm		2026-10-15

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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	49348-198		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-198	49348-198-78	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
49348-198-78	GM - Gram	49348-198	cddff203-d4e0-4f2b-8a80-3c7f0b501eb1	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-198	SUNMARK HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [STRATEGIC SOURCING SERVICES LLC]	4	Legacy NDC	20241106_96272510-a5ac-45eb-b693-4ccd1df85405.zip

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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-198-78	49348019878	1 TUBE in 1 CARTON (49348-198-78) > 57 g in 1 TUBE	1 tube	2016-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Hemorrhoidal Ointment Drug Facts	Strategic Sourcing Services LLC	2024-11-05	HUMAN OTC DRUG LABEL	4