FDA.reportPublic FDA data

Sore Throat

Product NDC
51316-199
11-digit product format
513160199
Labeler code
51316
Product ID
51316-199_aedc6546-b604-468c-8a1b-f89e871f9d31
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol Glycerin
Dosage form
SPRAY
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-25
Substance
PHENOL; GLYCERIN
Active strength
1.5; 33 mg/100mL; mg/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Sore Throat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOL1.5 mg/100mL
GLYCERIN33 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
339NCG44TVInternal UNII lookup
PDC6A3C0OXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1101852Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9683bcfb-2f7e-48a4-aa79-500ee8df099aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-199-04Sore Throat118 mL in 1 BOTTLE, SPRAYSPRAY1182

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AHLO PRO Healthy GumsCETYLPYRIDINIUM CHLORIDEGervest USA Inc4f5a0ccb-26e5-ebb6-e063-6394a90abbc52026-04-13WarningsExact identifier
application number: M022
Crest Scope Original Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f1db6f4-acd7-a665-e063-6294a90a826b2026-04-10WarningsExact identifier
application number: M022
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
application number: M022
Sore throat cherryPHENOLWalgreens67bed85e-e1e2-49ba-98d6-dfd4e1cd68562026-04-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.5eb437c5-a2af-4c0d-b7b9-9ab7d093db852026-04-06WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)269b9e7f-c5c8-4023-a3ea-e39040ade2712026-04-06WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c3fb6705-c647-4fe6-9aca-29735d01d8ea2026-04-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea2026-04-01WarningsExact identifier
application number: M022
CloSYS Silver Healthy GumsCETYLPYRIDINIUM CHLORIDERowpar Pharmaceuticals, Inc.11fd3f31-ee0c-43d2-a856-929d1298277c2026-04-01WarningsExact identifier
application number: M022
Crest Pro-Health Bold Fresh BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company5692c0ce-a914-08c4-e063-6394a90adf152026-04-01WarningsExact identifier
application number: M022
Anticavity FluorideSODIUM FLUORIDE AND ACIDULATED PHOSPHATEFamily Dollar (FAMILY WELLNESS)1666fff6-9a8b-40f9-ae53-914152db386b2026-04-01WarningsExact identifier
application number: M022
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
application number: M022
Sootheez Birthday CakePECTINPrimrose Candy Co.4e5d8234-0521-0c8a-e063-6294a90ae62d2026-03-31WarningsExact identifier
application number: M022
Sootheez Watermelon MintPECTINPrimrose Candy Co.4e5e4342-4647-ef25-e063-6394a90a1d132026-03-31WarningsExact identifier
application number: M022
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC4e5a67a0-f989-50df-e063-6394a90aae732026-03-31WarningsExact identifier
application number: M022
PeriogelHYDROGEN PEROXIDEPERIO PROTECT, LLC1f9686b1-eac2-65b7-e063-6394a90a74fb2026-03-31WarningsExact identifier
application number: M022
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC1f7ecd75-bb59-2f4f-e063-6294a90ace842026-03-31WarningsExact identifier
application number: M022
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corped63df26-3879-46df-8e09-10be569b25be2026-03-31WarningsExact identifier
application number: M022
Benzocaine 20%BENZOCAINE 20%PAI Holdings, LLC dba PAI Pharma7fbce9a5-00dc-4a4a-8709-ab752bdf2f592026-03-25WarningsExact identifier
application number: M022
Kroger Extra WhiteningFLUORIDEKrogere704c690-1383-4cd6-be85-28bdd9ff936b2026-03-24WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101852glycerin 33 % / phenol 1.5 % Mucosal SprayPSN9683bcfb-2f7e-48a4-aa79-500ee8df099a2
1101852glycerin 330 MG/ML / phenol 15 MG/ML Mucosal SpraySCD9683bcfb-2f7e-48a4-aa79-500ee8df099a2
1101852glycerin 33 % / phenol 1.5 % Mucosal SpraySY9683bcfb-2f7e-48a4-aa79-500ee8df099a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-199-0451316019904118 mL in 1 BOTTLE, SPRAY (51316-199-04) 118 ml2025-12-25NoNoCurrent