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 31 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Red Cross Canker Sore	BENZOCAINE	The Mentholatum Company	54cfff96-6665-4b36-a15d-10bf6cf3a1f9	2024-12-17	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	116956644	2981217f-f250-c090-e063-6294a90a85b0	2024-12-17	Warnings	Exact identifier application number: M022
Kank-A Mouth Pain	BENZOCAINE	Blistex Inc.	eebc03ba-f849-4e70-a653-834f383b6aa4	2024-12-17	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	8282a4a6-b77c-75fc-e053-2991aa0ad4ac	2024-12-16	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories,Inc.	9452bff4-8c08-eff9-e053-2a95a90a67ed	2024-12-16	Warnings	Exact identifier application number: M022
PHENOL	PHENOL	CHAIN DRUG MARKETING ASSOCIATION INC.	2379e23a-72fe-4e94-9d7e-9b623c0db174	2024-12-13	Warnings	Exact identifier application number: M022
KANKA SoftBrush	BENZOCAINE AND ZINC CHLORIDE	Blistex Inc	093f3545-1d8e-48a3-a533-e9c3ae6d740b	2024-12-12	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	826eaef8-4457-3dc2-e053-2991aa0a528b	2024-12-11	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	8281700c-10f9-841c-e053-2991aa0a918f	2024-12-11	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	82824416-80de-76bd-e053-2a91aa0ad8b5	2024-12-11	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories,Inc.	e3da0e63-a891-72bd-e053-2a95a90a58bc	2024-12-11	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories, Inc.	e3d924b5-0788-46d3-e053-2995a90a027b	2024-12-11	Warnings	Exact identifier application number: M022
Fluoride Bits	SODIUM MONOFLUOROPHOSPHATE 0.76%	The Kind Lab, Inc.	fa433031-7376-0e5b-e053-6394a90a5f75	2024-12-11	Warnings	Exact identifier application number: M022
Fluoride Bits	SODIUM MONOFLUOROPHOSPHATE 0.76%	The Kind Lab, Inc.	eedf13dc-a009-027a-e053-2995a90a8ec8	2024-12-11	Warnings	Exact identifier application number: M022
NATURAL LEMON MINT HERB THROAT DROPS	MENTHOL	Ricola USA Inc.	763e8234-60be-4b1f-9f78-01c574f35d0a	2024-12-10	Warnings	Exact identifier application number: M022
Natural Cherry Honey Herb Throat Drops	MENTHOL	Ricola USA Inc.	989f8509-cd28-48e7-9aa1-baddfbcac95a	2024-12-10	Warnings	Exact identifier application number: M022
ORGANIC PEPPERMINT HERB THROAT DROPS	MENTHOL	Ricola USA Inc.	f75c8967-40e6-473a-b403-941354cb0be1	2024-12-10	Warnings	Exact identifier application number: M022
Natural Cherry Honey Herb Throat Drops	MENTHOL	Ricola USA Inc.	c56be34d-1dd5-4200-9723-3a73180cb759	2024-12-10	Warnings	Exact identifier application number: M022
Cherry Throat Drops	MENTHOL	Ricola USA Inc.	89257ceb-af0f-4516-88f7-6dfdab9e14f4	2024-12-10	Warnings	Exact identifier application number: M022
BERRY MEDLEY THROAT DROPS	MENTHOL	Ricola USA Inc.	9bfd2ea7-745b-47f8-bd8a-9dbeeaad8b95	2024-12-10	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