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	2026-10-12
excluded product	product	67751-178		D	Discontinued by firm	2026-10-12
excluded package	package	67751-178	67751-178-02	D	Discontinued by firm	2026-10-12
excluded package	package	67751-178	67751-178-03	D	Discontinued by firm	2026-10-12
excluded package	package	67751-178	67751-178-02	D	Discontinued by firm	2026-10-12
excluded package	package	67751-178	67751-178-03	D	Discontinued by firm	2026-10-12

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 39 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Multi-Symptom Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Valu Merchandisers Company	b0d9d869-9f0d-4834-aa2b-1ee21fd8b67b	2026-04-16	Warnings	Exact identifier application number: M012
Rompe Pecho Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	4f86985c-48f3-2148-e063-6394a90ae2f1	2026-04-15	Warnings	Exact identifier application number: M012
Childrens Daytime Mucus	DEXTROMETHORPHAN HBR	Walgreens	7a55b7e1-1054-421e-847e-5e4d90d1aebb	2026-04-15	Warnings	Exact identifier application number: M012
Childrens Nighttime Mucus	DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	Walgreens	dc69f581-27c7-4030-bb18-39685c7691a1	2026-04-15	Warnings	Exact identifier application number: M012
Pseudoephedrine HCl	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	da95c643-7122-4025-977f-42205080e56b	2026-04-15	Warnings	Exact identifier application number: M012
Daytime Nighttime Chewable	DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	Walgreens	9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c6	2026-04-15	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4f7090f4-89c9-c3da-e063-6294a90a4716	2026-04-14	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN, PHENYLEPHRINE HCL	Walgreen Company	2115f095-2d75-4e02-a6af-22dd693e0840	2026-04-14	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Lidl US LLC	00f89eee-0edc-40dc-9297-8645afb91004	2026-04-14	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	8647c136-a323-453a-8f57-e66938bbf639	2026-04-14	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	5515148f-3e1d-4b03-89fa-40967d508292	2026-04-14	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	c70e6506-6c5b-4d3f-ab18-a690840caabc	2026-04-13	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	Walgreen Company	48387b95-8240-4d6e-842b-cc29cc18709c	2026-04-13	Warnings	Exact identifier application number: M012
Sinufrin Plus No Drip Decongestant	NASAL CONGESTION RELIEF	NeilMed Pharmaceuticals Inc	4f06c732-1f9f-bfc6-e063-6394a90a53f5	2026-04-13	Warnings	Exact identifier application number: M012
Severe Sinus Congestion	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	8745d9d8-640d-4e3b-96fe-d25032c1e3ce	2026-04-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	5a5c5f33-5b70-465d-a38b-6f518af09788	2026-04-13	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	Publix Super Markets Inc	f2263e38-f686-45ed-bf85-b47f5e1aa982	2026-04-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	BETTER LIVING BRANDS, LLC	46adbf94-5b93-ee64-e063-6294a90a1144	2026-04-11	Warnings	Exact identifier application number: M012
good sense night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L. Perrigo Company	0c79357a-b79d-4952-8e6d-ef3d60dde2fa	2026-04-10	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	88d27c25-a305-4398-9590-df10d2504b01	2026-04-09	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#