Quality Choice Cold and Sore Throat

Product NDC: 63868-765
11-digit product format: 638680765
Labeler code: 63868
Product ID: 63868-765_28c4fcc2-0a53-1752-e054-00144ff8d46c
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Pheniramine Maleate, Phenylephrine HCl
Dosage form: GRANULE, FOR SOLUTION
Route: ORAL
Labeler: Chain Drug Marketing Association
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-07-25
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 mg/1; mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63868-765		I	Inactivated by FDA		2026-10-20
excluded package	package	63868-765	63868-765-06	I	Inactivated by FDA		2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-765-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-765-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-765-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-765-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-765-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-765-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63868-765-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63868-765-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63868-765-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63868-765-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63868-765-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63868-765-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63868-765-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63868-765-06	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63868-765-06	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63868-765-06	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63868-765-06	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63868-765-06	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63868-765-06	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63868-765-06	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63868-765-06	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-765-06	2020-01-31	C162847	48780-1	9d75b9d0-2794-f424-e053-dadaa90a57ce	Quality Choice Cold and Sore Throat Lemon Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-765-06	Quality Choice Cold and Sore ThroatLemon Flavor	6 in 1 BOX	GRANULE, FOR SOLUTION	6		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Pheniramine Maleate	ACTIVE INGREDIENT	NYW905655B	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Phenylephrine hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Pheniramine	ACTIVE MOIETY	134FM9ZZ6M	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Ascorbic acid	INACTIVE INGREDIENT	PQ6CK8PD0R	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Ethylcellulose (100 MPA.S)	INACTIVE INGREDIENT	47MLB0F1MV	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Povidone	INACTIVE INGREDIENT	FZ989GH94E	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-765	QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]	2	Legacy NDC, 1 package rows	20160108_7047e4b8-d111-4540-89e0-5f29dc17a03d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
NYW905655B	PHENIRAMINE MALEATE	132-20-7	PHENIRAMINE MALEATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution	PSN	7047e4b8-d111-4540-89e0-5f29dc17a03d	2
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution	SCD	7047e4b8-d111-4540-89e0-5f29dc17a03d	2
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Granule for Oral Solution	SY	7047e4b8-d111-4540-89e0-5f29dc17a03d	2
1796460	acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Packet for Oral Solution	SY	7047e4b8-d111-4540-89e0-5f29dc17a03d	2
1796460	APAP 325 MG / Pheniramine Maleate 20 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution	SY	7047e4b8-d111-4540-89e0-5f29dc17a03d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63868-765-06	63868076506	6 in 1 BOX	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice Cold and Sore Throat Lemon Flavor	Chain Drug Marketing Association	2016-01-07	HUMAN OTC DRUG LABEL	2