Handy Solutions Sinus Congestion and Pain Relief

Product NDC: 67751-178
11-digit product format: 677510178
Labeler code: 67751
Product ID: 67751-178_f18af79a-4939-2cf2-e053-2a95a90a0205
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Navajo Manufacturing Company Inc.
Application: M012
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-10-22
Marketing end: 2024-07-01
Substance: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67751-178		D	Discontinued by firm	2026-10-15
excluded product	product	67751-178		D	Discontinued by firm	2026-10-15
excluded package	package	67751-178	67751-178-02	D	Discontinued by firm	2026-10-15
excluded package	package	67751-178	67751-178-03	D	Discontinued by firm	2026-10-15
excluded package	package	67751-178	67751-178-02	D	Discontinued by firm	2026-10-15
excluded package	package	67751-178	67751-178-03	D	Discontinued by firm	2026-10-15

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 2 · 72 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67751-178-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67751-178-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67751-178-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67751-178-03	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67751-178-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67751-178-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67751-178-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67751-178-03	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67751-178-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67751-178-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67751-178-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67751-178-03	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67751-178-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67751-178-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67751-178-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67751-178-03	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67751-178-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67751-178-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67751-178-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67751-178-03	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67751-178-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67751-178-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67751-178-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67751-178-03	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67751-178-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67751-178-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67751-178-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67751-178-03	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67751-178-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67751-178-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67751-178-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67751-178-03	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67751-178-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67751-178-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67751-178-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67751-178-03	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67751-178-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67751-178-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67751-178-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67751-178-03	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

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

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 74 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cherry cough drops	MENTHOL	Meijer	5bc2ec81-a3cb-3a59-e053-2a91aa0ac14e	2025-12-18	Warnings	Exact identifier application number: M012
cherry cough drops	MENTHOL	Meijer	5bc3b9b8-e61e-1041-e053-2a91aa0a3d83	2025-12-18	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Meijer	5bd35bce-cd85-5314-e053-2991aa0abce6	2025-12-18	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Meijer	5bd42654-56e5-997e-e053-2a91aa0afd34	2025-12-18	Warnings	Exact identifier application number: M012
sugar free menthol cough drops	MENTHOL	Meijer	5bd61cd4-a5ca-9d66-e053-2a91aa0a93a3	2025-12-18	Warnings	Exact identifier application number: M012
sugar free honey lemon cough drops	MENTHOL	Meijer	5bd7c24d-6a61-5d2d-e053-2a91aa0a08ed	2025-12-18	Warnings	Exact identifier application number: M012
SF Honey Lemon Cough Drops	MENTHOL	Meijer Distribution	70e3de9a-1804-ef15-e053-2a95a90a3340	2025-12-18	Warnings	Exact identifier application number: M012
QUALITY CHOICE Cough Drops Vanilla Honey	MENTHOL	Chain Drug Marketing Association, Inc.	3d6a4bcc-1044-40f5-928a-378ececcb687	2025-12-18	Warnings	Exact identifier application number: M012
Meijer Strawberry Cough Drops	MENTHOL	Meijer	164de637-e644-711c-e063-6294a90a1c5f	2025-12-18	Warnings	Exact identifier application number: M012
Meijer Severe Menthol Throat Drops	MENTHOL	Meijer	16603ca4-1ce5-2e7e-e063-6394a90ad6f1	2025-12-18	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	A-S Medication Solutions	60587987-c303-4617-ba96-c518ab2a0650	2025-12-18	Warnings	Exact identifier application number: M012
Niaflu	DEXTROMETHORPHAN HBR, GUAIFENESIN	Pharmadel LLC	399898f0-e40a-4f5d-e063-6294a90a667d	2025-12-17	Warnings	Exact identifier application number: M012
Cherry cough drop	MENTHOL	The Kroget Co.	4313a6ce-454d-4c4b-e054-00144ff88e88	2025-12-17	Warnings	Exact identifier application number: M012
Menthol cough drop	MENTHOL	The Kroger Co.	42b257e9-f45e-32c9-e054-00144ff8d46c	2025-12-17	Warnings	Exact identifier application number: M012
Honey Lemon cough drop	MENTHOL	The Kroger Co.	4318f25a-05d9-2208-e054-00144ff88e88	2025-12-17	Warnings	Exact identifier application number: M012
Honey Lemon cough drop	MENTHOL	The Kroger Co.	4317f952-a228-0281-e054-00144ff88e88	2025-12-17	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drop	MENTHOL	The Kroger Co.	4316df6e-3ae6-4ab5-e054-00144ff88e88	2025-12-17	Warnings	Exact identifier application number: M012
SF Honey Lemon Cough Drops	MENTHOL	The Kroger Co.	43281bd1-f8a7-02a4-e054-00144ff8d46c	2025-12-17	Warnings	Exact identifier application number: M012
Kroger Cherry Cough Drops	MENTHOL	Kroger	a2e1d1f5-9b19-1704-e053-2a95a90abb51	2025-12-17	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE	Major Pharmaceuticals	a9958b7d-7060-422b-a098-c1925c246081	2025-12-17	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67751-178-02	67751017802	2 TABLET in 1 POUCH (67751-178-02)	2 tablet	2016-10-22	0000-00-00	No	No	Current
67751-178-03	67751017803	3 POUCH in 1 CARTON (67751-178-03) > 2 TABLET in 1 POUCH	3 pouch	2016-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Handy Solutions Sinus Congestion & Pain Relief	Navajo Manufacturing Company Inc. \| Ultra Seal Corporation \| ULTRAtab Laboratories, Inc.	2023-01-05	HUMAN OTC DRUG LABEL	5

Handy Solutions Sinus Congestion and Pain Relief

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#