FDA.reportPublic FDA data

Sore Throat Relief

Product NDC
70000-0458
11-digit product format
700000458
Labeler code
70000
Product ID
70000-0458_411c779f-85c0-167a-e063-6294a90a5148
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
Cardinal Health
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-12
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 Throat Relief Cherry FlavorPHENOLCardinal Healthb84203bd-23e9-427d-83d8-f4c88266e23c2025-10-14WarningsExact 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 administer to children under 6 years of age unless directed by a doctor. When using this product, do not exceed recommended dose. Stop use and ask a doctor or dentist 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 doctor before use. Keep out of reach of children. In case of overdose or accidental poisoning , get medical help or contact a Poison Control Center right away (1-800-222-1222).

Additional Listing Data#

Finished product
Yes
Brand name base
Sore Throat Relief
Brand name suffix
Cherry Flavor
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
70000-0458-1Sore Throat ReliefCherry Flavor177 mL in 1 BOTTLE, SPRAYSPRAY1777

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0458-1ML - Milliliter70000-0458df9d0474-a19a-45df-8bb4-e91249b6515c12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0458SORE THROAT RELIEF CHERRY FLAVOR (PHENOL) SPRAY [CARDINAL HEALTH]6Current NDC, Legacy NDC, 1 package rows20241122_b84203bd-23e9-427d-83d8-f4c88266e23c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSNb84203bd-23e9-427d-83d8-f4c88266e23c7
198776phenol 14 MG/ML Mucosal SpraySCDb84203bd-23e9-427d-83d8-f4c88266e23c7
198776phenol 1.4 % Mucosal SpraySYb84203bd-23e9-427d-83d8-f4c88266e23c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0458-170000045801177 mL in 1 BOTTLE, SPRAY (70000-0458-1) 177 ml2019-02-120000-00-00NoNoCurrent