Sunmark Cold and Allergy

Product NDC: 49348-777
Requested package NDC: 49348-777-34
11-digit product format: 493480777
Labeler code: 49348
Product ID: 49348-777_4fb1391c-7232-4f1c-91b7-b58bc2c78418
Type: HUMAN OTC DRUG
Nonproprietary name: phenylephrine hcl, brompheniramine maleate
Dosage form: SOLUTION
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2006-09-11
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE
Active strength: 5 mg/10mL; mg/10mL
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	49348-777	49348-777-34	D	Discontinued by firm		2026-10-12

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-777-34	ML - Milliliter	49348-777	57fe7135-bb10-4b8f-9e49-6e7b9f065c38	1	2012-07-24
49348-777-37	ML - Milliliter	49348-777	e9652af1-683f-4495-9c9f-3b3cc638c47c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	SUNMARK COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [MCKESSON]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SUNMARK COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [MCKESSON]	1
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	SUNMARK COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [MCKESSON]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SUNMARK COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [MCKESSON]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	e7a01146-6183-4dde-8acd-5a3c95dc555d	1
1053258	brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	e7a01146-6183-4dde-8acd-5a3c95dc555d	1
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Elixir	SY	e7a01146-6183-4dde-8acd-5a3c95dc555d	1
1053258	brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	e7a01146-6183-4dde-8acd-5a3c95dc555d	1
1053258	brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	e7a01146-6183-4dde-8acd-5a3c95dc555d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-777-34	49348077734	1 BOTTLE in 1 CARTON (49348-777-34) > 118 mL in 1 BOTTLE	1 bottle	2006-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Cold & Allergy Drug Facts	A-S Medication Solutions	2020-01-28	HUMAN OTC DRUG LABEL	1
McKesson Cold & Allergy Drug Facts	Strategic Sourcing Services LLC	2019-09-03	HUMAN OTC DRUG LABEL	5