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NDC 49348-0991-36 Sore Throat 1.4 g/100mL Details

Sore Throat 1.4 g/100mL

Sore Throat is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is PHENOL.

Product Information

NDC	49348-0991
Product ID	49348-991_a456cda4-cd0f-4e24-a359-bbd01d0351b8
Associated GPIs	88150070000935
GCN Sequence Number	016026
GCN Sequence Number Description	phenol SPRAY 1.4 % MUCOUS MEM
HIC3	H0A
HIC3 Description	LOCAL ANESTHETICS
GCN	48591
HICL Sequence Number	004295
HICL Sequence Number Description	PHENOL
Brand/Generic	Generic
Proprietary Name	Sore Throat
Proprietary Name Suffix	Cherry
Non-Proprietary Name	Phenol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	ORAL
Active Ingredient Strength	1.4
Active Ingredient Units	g/100mL
Substance Name	PHENOL
Labeler Name	Strategic Sourcing Services LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	n/a

Package

Package Images

NDC 49348-0991-36 (49348099136)

Pricing Information
NDC Package Code	49348-991-36
Billing NDC	49348099136
Package	177 mL in 1 BOTTLE, SPRAY (49348-991-36)
Marketing Start Date	2014-09-30
NDC Exclude Flag	N
Price Per Unit	0.0122
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	SM SORE THROAT 1.4% SPRAY
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL c004b55b-79c6-44e8-acce-fcc019786005 Details

Active ingredient

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

Uses

temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied with high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age.

When using this product,

do not exceed recommended dose.

Stop use and ask a dentist or doctor if

sore mouth symptoms do not improve in 7 days
irritation, pain or redness persists or worsens
swelling, rash or fever develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children 6 years of age and older
- apply to affected area (one spray)
- allow to remain in place for at least 15 seconds, then spit out
- use every 2 hours as directed by a doctor or dentist
children under 12 years of age should be supervised in the use of this product
children under 6 years of age, consult a doctor or dentist

Other information

store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

alcohol, FD&C red #40, glycerin, flavor, purified water, saccharin sodium

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO CHLORASEPTIC® ACTIVE INGREDIENT*

Sore Throat Spray

Fast-acting, long-lasting relief of minor sore throat & mouth pain

Alcohol 0.10%

PHENOL 1.4% ORAL ANESTHETIC

CHERRY FLAVOR

FL OZ (mL)

*This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

www.sunmarkbrand.com

Package Label

SUNMARK Sore Throat Spray

INGREDIENTS AND APPEARANCE

SORE THROAT CHERRY

phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-991
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49348-991-36	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/30/2014	08/29/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	09/30/2014	08/29/2025

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 11/2022

Document Id: a456cda4-cd0f-4e24-a359-bbd01d0351b8

Set id: c004b55b-79c6-44e8-acce-fcc019786005

Version: 7

Effective Time: 20221108