Sore Throat

Product NDC: 49580-0376
11-digit product format: 495800376
Labeler code: 49580
Product ID: 49580-0376_b0aae576-6544-4bc5-af3c-d7edb7c7a35c
Type: HUMAN OTC DRUG
Nonproprietary name: Phenol
Dosage form: SPRAY
Route: ORAL
Labeler: P & L Development, LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-11-30
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: ReadyInCase
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
2fb3d17e-8ca3-4edb-8b82-4b484f42616e	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49580-0376-6	2023-06-01	C162847	48780-1	f386c649-ea52-0266-e053-dadaa90a7c1a	Drug Facts
49580-0376-6	2023-01-30	C162847	48780-1	f386c649-ea52-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49580-0376-6	Sore ThroatReadyInCase	177 mL in 1 BOTTLE, SPRAY	SPRAY	177		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENOL	ACTIVE INGREDIENT	339NCG44TV	SORE THROAT READYINCASE (PHENOL) SPRAY [AARON INDUSTRIES INC.]	1
PHENOL	ACTIVE MOIETY	339NCG44TV	SORE THROAT READYINCASE (PHENOL) SPRAY [AARON INDUSTRIES INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	SORE THROAT READYINCASE (PHENOL) SPRAY [AARON INDUSTRIES INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SORE THROAT READYINCASE (PHENOL) SPRAY [AARON INDUSTRIES INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SORE THROAT READYINCASE (PHENOL) SPRAY [AARON INDUSTRIES INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	SORE THROAT READYINCASE (PHENOL) SPRAY [AARON INDUSTRIES INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SORE THROAT READYINCASE (PHENOL) SPRAY [AARON INDUSTRIES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49580-0376	SORE THROAT READYINCASE (PHENOL) SPRAY [P & L DEVELOPMENT, LLC]	8	Current NDC, Legacy NDC, 1 package rows	20241115_2fb3d17e-8ca3-4edb-8b82-4b484f42616e.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 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oral Gel Oral Pain Relief	BENZOCAINE BENZALKONIUM CHLORIDE	Savvy Care and Cosmetics	05ede7e4-5a0a-c942-e063-6294a90a8a24	2024-12-19	Warnings	Exact identifier application number: M022
EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint	SODIUM BICARBONATE	Lotus Brands, Inc.	4a95c8c1-db7c-4791-ac58-3eac216a0126	2024-12-18	Warnings	Exact identifier application number: M022
EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon	SODIUM BICARBONATE	Lotus Brands, Inc.	6703b29d-cdc9-4c74-91c0-fb0c98dd043e	2024-12-18	Warnings	Exact identifier application number: M022
Red Cross Oral Pain Relief	BENZOCAINE	The Mentholatum Company	cbd41429-f730-4577-9f06-ef1831cf62e1	2024-12-17	Warnings	Exact identifier application number: M022
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

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	2fb3d17e-8ca3-4edb-8b82-4b484f42616e	9
198776	phenol 14 MG/ML Mucosal Spray	SCD	2fb3d17e-8ca3-4edb-8b82-4b484f42616e	9
198776	phenol 1.4 % Mucosal Spray	SY	2fb3d17e-8ca3-4edb-8b82-4b484f42616e	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49580-0376-6	49580037606	177 mL in 1 BOTTLE, SPRAY (49580-0376-6)	177 ml	2014-11-30	0000-00-00	No	No	Current