Sore Throat

Product NDC
63868-811
11-digit product format
638680811
Labeler code
63868
Product ID
63868-811_0d8fa5c2-989b-43cf-bec4-0d10eb4dfa27
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-31
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
Brand name suffix
Cherry
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
9162ae27-ddbb-4336-9655-487995919de4Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-811-552023-05-11C16284748780-1f386c649-f056-0266-e053-dadaa90a7c1aDrug Facts
63868-811-552023-01-30C16284748780-1f386c649-f056-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-811-55Sore ThroatCherry177 mL in 1 BOTTLE, SPRAYSPRAY1775

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-811-55ML - Milliliter63868-8118f24b435-991e-4848-bdb6-7a654305fa5412014-10-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-811SORE THROAT CHERRY (PHENOL) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5Current NDC, Legacy NDC, 1 package rows20240502_9162ae27-ddbb-4336-9655-487995919de4.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 28 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PureLife Topical AnestheticBENZOCAINEPureLife Dental9f2bdc10-6b41-4606-a65c-560d204fdb972025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dentalea8e5036-8c30-4527-9f0b-5c474bb0debd2025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dentalf9b9b085-ff61-4771-8d41-758bd061d9082025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental8c2cec48-d19c-45b5-9f9a-c35358f369272025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.e629fbd0-7dc7-4c26-b221-6c5db80faa3c2025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.170ce528-7115-463c-b360-1d7a958bbd812025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.2a93e8fb-bb0d-4b0f-b5e7-ff1fe4ebb7982025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c85e741b-da75-44ce-805e-5dde39795bd92025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.9fb0c45e-19b1-4b3b-adb7-e467bde03aa42025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentalc75195b6-f8b4-4fda-a162-5dd95bd9ab312025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentalb6e25b54-4734-4769-9d1e-2d1187fdae192025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental1142e94e-0de1-4e8a-8eaf-a8dc0d08a2902025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.9a9d71ff-121c-f6af-e053-2995a90ad27f2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4429a22e-2e3e-4519-b0a3-c1d86a62aba22025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental89b7e919-2656-4b1b-ab5c-5b11d42b52f32025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental05cf428c-3bc8-5fcb-e063-6394a90a962a2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental3cc5d095-5f9c-4e4d-8971-0079e949b7ca2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental89d23b14-398e-4b3e-955a-724ff66579b92025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentale381b2d5-6485-4d11-94f4-eec335d5cf412025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental8ffc4af6-d99c-4964-8d7d-4644bc699a3d2025-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSN9162ae27-ddbb-4336-9655-487995919de45
198776phenol 14 MG/ML Mucosal SpraySCD9162ae27-ddbb-4336-9655-487995919de45
198776phenol 1.4 % Mucosal SpraySY9162ae27-ddbb-4336-9655-487995919de45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-811-5563868081155177 mL in 1 BOTTLE, SPRAY (63868-811-55) 177 ml2014-08-310000-00-00NoNoCurrent