Home NDC 51316-199-04 Sore Throat
Product NDC 51316-199
Requested package NDC 51316-199-04
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 Ingredient Strength PHENOL 1.5 mg/100mL GLYCERIN 33 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 339NCG44TV Internal UNII lookup PDC6A3C0OX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1101852 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51316-199-04 Sore Throat 118 mL in 1 BOTTLE, SPRAY SPRAY 118 2
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 7 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lemon Glycerin GLYCERIN Dynarex Corporation 99fc00ea-9d55-0380-e053-2995a90a2c0b 2026-03-24 Warnings Exact identifier application number: M022 Dual-FormulaToothpaste for sensitive teeth DUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETH Hangzhou Namei Zhikang Technology Co., Ltd. 4d735f91-8abc-3a30-e063-6394a90a7639 2026-03-20 Warnings Exact identifier application number: M022 SmileCare Mouth Ulcer Gel MENTHOL Yantai Aien Biotechnology Co., Ltd. 4d6db039-5b97-8f3f-e063-6294a90a9d85 2026-03-19 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f91e609-8ca5-0492-e053-2a95a90a85d0 2026-03-17 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f81ffa5-05fd-4eef-e053-2995a90aac3e 2026-03-17 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f947366-9380-3fa9-e053-2a95a90ad49c 2026-03-17 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f947672-4873-5546-e053-2a95a90a3c4b 2026-03-17 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f9490c1-8bfe-3166-e053-2a95a90a7175 2026-03-17 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f94b65d-47e3-9c6b-e053-2a95a90aa1f8 2026-03-17 Warnings Exact identifier application number: M022 BencoCaine Topical Anesthetic BENZOCAINE Benco Dental 4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b 2026-03-17 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043c00a6-1346-7780-e063-6294a90a3d5a 2026-03-12 Warnings Exact identifier application number: M022 ORAL PAIN RELIEF BENZOCAINE Nantong Health & Beyond Hygienic Products Inc. a5f0be98-d47e-4307-8044-304a64db774b 2026-03-11 Warnings Exact identifier application number: M022 SENSODYNE PRONAMEL Intensive Enamel Repair Whitening POTASSIUM NITRATE AND SODIUM FLUORIDE Haleon US Holdings LLC a2f9d58b-671b-4427-a971-1fceff5f2323 2026-03-09 Warnings Exact identifier application number: M022 Sore Mouth Cleanser HYDROGEN PEROXIDE CVS Pharmacy, Inc. a5dbaadf-76a8-4c48-af2d-f4455e9411f0 2026-03-09 Warnings, Adverse reactions Exact identifier application number: M022 Hydrogen Peroxide 3 Percent HYDROGEN PEROXIDE Sam's West, Inc 78a3e024-73da-40b7-9d9c-099fd6ca9b9e 2026-03-03 Warnings Exact identifier application number: M022 Sore Throat PHENOL GLYCERIN CVS PHARMACY, INC 9683bcfb-2f7e-48a4-aa79-500ee8df099a 2026-03-02 Warnings Exact identifier application number: M022 ndc (package): 51316-199-04 ndc (product): 51316-199 ndc11 (package): 51316019904 Spring Gene Oil Pulling Sensitivity POTASSIUM NITRATE Health and Natural Beauty USA Corp 294051e3-69ec-4190-8b03-fa34988376b7 2026-02-26 Warnings Exact identifier application number: M022 Lolleez Watermelon PECTIN BFY LLC 4ba8af8b-5a17-8b8c-e063-6394a90a63f3 2026-02-25 Warnings Exact identifier application number: M022 Oral Sore Antiseptic HYDROGEN PEROXIDE, MENTHOL H E B f1450866-1be4-46d9-9fe4-52d699636b4f 2026-02-24 Warnings, Adverse reactions Exact identifier application number: M022 SIGNATURE CARE SORE THROAT CHERRY FLAVOR PHENOL SAFEWAY 94a2c1b9-f462-4489-b84a-825a82835d30 2026-02-23 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-199-04 51316019904 118 mL in 1 BOTTLE, SPRAY (51316-199-04) 118 ml 2025-12-25 No No Current