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 76 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEB SF Honey Lemon Cough Drops	MENTHOL	HEB	d09ed4bb-7595-5e54-e053-2a95a90aa109	2025-12-13	Warnings	Exact identifier application number: M012
HEB Cherry Cough Drops	MENTHOL	HEB	c198e3c7-5ba7-ece6-e053-2995a90adb38	2025-12-13	Warnings	Exact identifier application number: M012
HEB Honey Lemon Cough Drops	MENTHOL	HEB	c19a79bc-9872-2e87-e053-2a95a90a9427	2025-12-13	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	WALMART INC.	26f55169-4b37-4a36-88ee-064d6e962065	2025-12-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	39ce76a3-b7a8-43be-9b61-5c1446cd9e90	2025-12-12	Warnings	Exact identifier application number: M012
Cold and Flu maximum strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	ac01206f-a717-4c0b-8a03-fab0a4fd154b	2025-12-12	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	dcb80dd5-465d-4792-947a-3044e25a5284	2025-12-12	Warnings	Exact identifier application number: M012
Vapor Rub	COUGH SUPPRESSANT	Neilmed Pharmaceuticals Inc.	39190f9f-8a5a-e4d8-e063-6294a90a57dd	2025-12-12	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Cardinal Health, 110 dba LEADER	b7393668-1450-4e85-9793-d400daf39b43	2025-12-12	Warnings	Exact identifier application number: M012
Allergy Relief, 24-7 Life by 7-Eleven	DIPHENHYDRAMINE HCL TABLET, FILM COATED	Lil' Drug Store Products, Inc.	45c4cd6c-327d-5950-e063-6394a90a3a21	2025-12-12	Warnings	Exact identifier application number: M012
Menthol cough drops	MENTHOL	Family Dollar	44bb3b95-b2ba-470e-e054-00144ff88e88	2025-12-12	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	Family Dollar	44bb9c7b-994b-4ab8-e054-00144ff8d46c	2025-12-12	Warnings	Exact identifier application number: M012
cherry cough drops	MENTHOL	Family Dollar	44be9837-f15a-09f2-e054-00144ff8d46c	2025-12-12	Warnings	Exact identifier application number: M012
cherry cough drops	MENTHOL	Family Dollar	44bcae39-2389-09ee-e054-00144ff8d46c	2025-12-12	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Family Dollar	46635813-66c4-504c-e054-00144ff8d46c	2025-12-12	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Family Dollar	455b0f4b-0526-2361-e054-00144ff8d46c	2025-12-12	Warnings	Exact identifier application number: M012
Family Wellness Strawberry Cough Drops	MENTHOL	Family Dollar	f92466ac-dd93-9ac5-e053-6294a90a9291	2025-12-12	Warnings	Exact identifier application number: M012
GoodSense Menthol Cough Drops	MENTHOL	Geiss, Destin, Dunn	c6b25d69-8930-6867-e053-2a95a90ad208	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense Cherry Cough Drops	MENTHOL	Geiss, Destin, Dunn	c72db7f0-9324-8ed2-e053-2995a90a9868	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense Honey Lemon Cough Drops	MENTHOL	Geiss, Destin, Dunn	c72e557f-0211-81b9-e053-2995a90a1437	2025-12-12	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#