FDA.reportPublic FDA data

Sore Throat

Product NDC
11822-3109
11-digit product format
118223109
Labeler code
11822
Product ID
11822-3109_89ba31e5-ef06-44e4-a9f4-8d8cdc4bcce2
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
Rite Aid Corporation
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-10-08
Marketing end
0000-00-00
Substance
PHENOL
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11822-3109DDiscontinued by firm2026-10-23
excluded packagepackage11822-310911822-3109-8DDiscontinued by firm2026-10-23

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3109-8Sore Throat177 mL in 1 BOTTLE, SPRAYSPRAY1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3109SORE THROAT (PHENOL) SPRAY [RITE AID CORPORATION]3Legacy NDC, 1 package rows20241113_2858d1c1-f96f-42b7-886c-b8c14286e8ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSN2858d1c1-f96f-42b7-886c-b8c14286e8ba4
198776phenol 14 MG/ML Mucosal SpraySCD2858d1c1-f96f-42b7-886c-b8c14286e8ba4
198776phenol 1.4 % Mucosal SpraySY2858d1c1-f96f-42b7-886c-b8c14286e8ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-3109-811822310908177 mL in 1 BOTTLE, SPRAY (11822-3109-8) 177 ml2021-10-080000-00-00NoNoCurrent