Sore Throat

Product NDC
21130-376
11-digit product format
211300376
Labeler code
21130
Product ID
21130-376_624a1da9-c592-47cc-af35-e4f2b43a10c8
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
Safeway, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-30
Substance
PHENOL
Active strength
1.4 g/100mL
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
PHENOL1.4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198776Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-376-062023-05-10C16284748780-1f386c649-fa49-0266-e053-dadaa90a7c1aDrug Facts
21130-376-062023-01-30C16284748780-1f386c649-fa49-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-376-06Sore Throat177 mL in 1 BOTTLE, SPRAYSPRAY1779

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOLACTIVE INGREDIENT339NCG44TVSORE THROAT (PHENOL) SPRAY [SAFEWAY, INC.]3
PHENOLACTIVE MOIETY339NCG44TVSORE THROAT (PHENOL) SPRAY [SAFEWAY, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MSORE THROAT (PHENOL) SPRAY [SAFEWAY, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASORE THROAT (PHENOL) SPRAY [SAFEWAY, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSORE THROAT (PHENOL) SPRAY [SAFEWAY, INC.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSORE THROAT (PHENOL) SPRAY [SAFEWAY, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RSORE THROAT (PHENOL) SPRAY [SAFEWAY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-376SORE THROAT (PHENOL) SPRAY [SAFEWAY, INC.]9Current NDC, Legacy NDC, 1 package rows20241116_f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d.zip

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 15 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Sensitive Whitening TPSODIUM FLUORIDETargetab9a129e-337b-31fe-e053-2995a90ac6912025-11-14WarningsExact identifier
application number: M022
Signature Care Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDESafeway83225fe5-0490-eb4b-e053-2a91aa0a68792025-11-14WarningsExact identifier
application number: M022
Rite Aid Extra WhiteningFLUORIDERite Aidefe2c6c1-b8c6-4a52-b3c6-c9bfca4505702025-11-14WarningsExact identifier
application number: M022
Sound Body Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEBig Lots Stores, Inc.81a0a712-76e1-133f-e053-2a91aa0a001a2025-11-14WarningsExact identifier
application number: M022
Top Care Enamel GuardFLUORIDETOPCO Assoc. LLC8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c2025-11-14WarningsExact identifier
application number: M022
Care One Maximum StrengthFLUORIDEAmerican Sales24715cc7-cf02-4ea0-a491-2a111ad3660e2025-11-14WarningsExact identifier
application number: M022
Kroger Enamel Protection Sensitive Gentle WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDEKroger Company82b9a954-2a53-ac56-e053-2991aa0abd0e2025-11-13WarningsExact identifier
application number: M022
Sensitive Extra WhiteningSODIUM FLUORIDEPublix Super Market16eddce3-03e4-4c0e-e063-6294a90ae94d2025-11-13WarningsExact identifier
application number: M022
Pronamel Repair WhiteningPRONAMEL REPAIR WHITENINGPublix Super Market Inc16ee2625-3641-205d-e063-6394a90a742f2025-11-13WarningsExact identifier
application number: M022
Rite Aid Maximum StrengthBENZOCAINERite Aid340ccdab-0a02-454c-8d44-ced5667276ab2025-11-13WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINECVSa7572c4f-089b-0e80-e053-2a95a90a0ddf2025-11-13WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINEWalgreensad509f2a-05de-6c77-e053-2995a90ae5262025-11-13WarningsExact identifier
application number: M022
TopCare Oral Pain Relief Maximum StrengthBENZOCAINETopco Associates LLC835fb6ac-dbb7-5566-e053-2991aa0af5e22025-11-13WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum GelBENZOCAINEWalgreensa71c47de-d35d-49da-e053-2995a90a823c2025-11-13WarningsExact identifier
application number: M022
4X Medicated Toothache and Gum GelBENZOCAINEWalmarta471a858-edbf-c31e-e053-2995a90a71562025-11-13WarningsExact identifier
application number: M022
4X Medicated Severe Toothache and Gum CreamBENZOCAINERite Aid996fdbeb-1fe3-77b6-e053-2995a90a25c72025-11-13WarningsExact identifier
application number: M022
Topco 4x Medicated Toothache and Gum GelBENZOCAINETopCareb463ea94-08a9-ca5d-e053-2a95a90a224b2025-11-13WarningsExact identifier
application number: M022
4X Medicated Severe Toothache and Gum GelBENZOCAINERite Aid99703bf4-f169-5e05-e053-2995a90afab42025-11-13WarningsExact identifier
application number: M022
3X Medicated Mouth Sore GelBENZOCAINERite Aid997064c9-24bb-7fb1-e053-2995a90ace7c2025-11-13WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC8d187823-7e56-441b-8bca-8f03e7bb07c72025-11-12WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSNf1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d9
198776phenol 14 MG/ML Mucosal SpraySCDf1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d9
198776phenol 1.4 % Mucosal SpraySYf1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-376-0621130037606177 mL in 1 BOTTLE, SPRAY (21130-376-06) 177 ml2014-11-300000-00-00NoNoCurrent