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
Ingredient	Strength
PHENOL	1.4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
339NCG44TV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9162ae27-ddbb-4336-9655-487995919de4	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-811-55	2023-05-11	C162847	48780-1	f386c649-f056-0266-e053-dadaa90a7c1a	Drug Facts
63868-811-55	2023-01-30	C162847	48780-1	f386c649-f056-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-811-55	Sore ThroatCherry	177 mL in 1 BOTTLE, SPRAY	SPRAY	177		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-811-55	ML - Milliliter	63868-811	8f24b435-991e-4848-bdb6-7a654305fa54	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENOL	ACTIVE INGREDIENT	339NCG44TV	SORE THROAT CHERRY (PHENOL) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
PHENOL	ACTIVE MOIETY	339NCG44TV	SORE THROAT CHERRY (PHENOL) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	SORE THROAT CHERRY (PHENOL) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SORE THROAT CHERRY (PHENOL) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SORE THROAT CHERRY (PHENOL) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	SORE THROAT CHERRY (PHENOL) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SORE THROAT CHERRY (PHENOL) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-811	SORE THROAT CHERRY (PHENOL) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	5	Current NDC, Legacy NDC, 1 package rows	20240502_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 34 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Cherry	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	a0e145c8-6b08-40be-ae4f-5678c4a78b1e	2024-10-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	Warnings	Exact identifier application number: M022
Chloraspetic	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	2b1808b2-2574-4ab8-a762-5733251848ce	2024-10-25	Warnings	Exact identifier application number: M022
Chloraseptic Warming Sore Throat	PHENOL	Prestige Brands Holdings, Inc.	a197fab2-70ce-4a6c-9add-29d7368a75c5	2024-10-25	Warnings	Exact identifier application number: M022
Gly-Oxide	CARBAMIDE PEROXIDE	Medtech Products Inc.	086a0b82-e947-41c9-89e7-ba06483960c9	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	d500f423-b9f2-4d98-8f2a-8bab7c05737c	2024-10-25	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
339NCG44TV	PHENOL	108-95-2	PHENOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198776	phenol 1.4 % Mucosal Spray	PSN	9162ae27-ddbb-4336-9655-487995919de4	5
198776	phenol 14 MG/ML Mucosal Spray	SCD	9162ae27-ddbb-4336-9655-487995919de4	5
198776	phenol 1.4 % Mucosal Spray	SY	9162ae27-ddbb-4336-9655-487995919de4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-811-55	63868081155	177 mL in 1 BOTTLE, SPRAY (63868-811-55)	177 ml	2014-08-31	0000-00-00	No	No	Current