FDA.reportPublic FDA data

SORE THROAT

Product NDC
68163-703
11-digit product format
681630703
Labeler code
68163
Product ID
68163-703_3fee162b-def4-ab8f-e063-6394a90ab899
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
Raritan Pharmaceuticals Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-29
Substance
PHENOL
Active strength
1.4 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2025-09-29WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Sore Throat Warning: Severe or persistent sore throat or sore throat that accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by doctor.

Additional Listing Data#

Finished product
Yes
Brand name base
SORE THROAT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOL1.4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii339NCG44TV
Rxcui198776

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-703-06SORE THROAT177 mL in 1 BOTTLE, SPRAYSPRAY1776

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-703SORE THROAT (PHENOL) SPRAY [RARITAN PHARMACEUTICALS INC]5Current NDC, Legacy NDC, 1 package rows20241124_43ce374a-824c-4034-bf04-c351b4d8015b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSN43ce374a-824c-4034-bf04-c351b4d8015b6
198776phenol 14 MG/ML Mucosal SpraySCD43ce374a-824c-4034-bf04-c351b4d8015b6
198776phenol 1.4 % Mucosal SpraySY43ce374a-824c-4034-bf04-c351b4d8015b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68163-703-0668163070306177 mL in 1 BOTTLE, SPRAY (68163-703-06) 177 ml2020-07-290000-00-00NoNoCurrent