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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | 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.
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Equate Menthol Chewable Gels | MENTHOL | Walmart | 1ba4b2be-7242-0a23-e063-6294a90af29c | 2025-12-23 | Warnings | M012 |
| Walgreens Severe Menthol Throat Drops | MENTHOL | Walgreens | 21dd3c68-cbc6-4799-e063-6394a90a6972 | 2025-12-23 | Warnings | M012 |
| cherry throat relief lozenges | BENZOCAINE | Zee Medical | 499d0748-538f-678c-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| Guaiasorb DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | NuCare Pharmaceuticals, Inc. | 46a480c7-7092-b809-e063-6294a90a60cd | 2025-12-23 | Warnings | M012 |
| menthol cough drops | MENTHOL | Winco Foods | 360a6304-206d-5475-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| menthol cough drops | MENTHOL | Winco Foods | 36342d8c-34ab-6178-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| cherry cough drops | MENTHOL | Winco Foods | 37244333-1307-5121-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | Winco foods | 37718c73-880e-4a5c-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | Winco Foods | 40676ddc-577f-5cc9-e054-00144ff88e88 | 2025-12-23 | Warnings | M012 |
| Sugar Free Menthol Cough Drops | MENTHOL | Winco Foods | 3788e8b6-ab9e-1513-e054-00144ff88e88 | 2025-12-23 | Warnings | M012 |
| SAFETUSSIN Non Drowsy Cough plus chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | eeca6370-29ea-4540-8139-e8461d58a286 | 2025-12-23 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Discount Drug Mart | dd31f86b-f59e-459a-8e5f-176828706a4a | 2025-12-23 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Discount Drug Mart | f8e7a08e-7422-4a1b-bfec-93e0b50d10cd | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | ab45ae97-7951-4058-e053-2995a90a7b2e | 2025-12-23 | Warnings | M012 |
| Childrens Chest Congestion Relief Grape | GUAIFENESIN | Discount Drug Mart | 3e5d245f-515c-4106-a855-fb97681b646a | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | ab45ed16-86bb-3faf-e053-2995a90acfbc | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | a7999da7-148a-4c6d-a2ea-0f4cc1d5b283 | 2025-12-23 | Warnings | M012 |
| Safetussin High Blood Pressure and diabetes Cough, Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 279e309c-040d-4001-808d-b7d986a9a1d8 | 2025-12-23 | Warnings | M012 |
| Sinus PE Head Congestion and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 76fd1f8e-2670-421c-a9e6-c8adefb7962e | 2025-12-23 | Warnings | M012 |
| Leader Cough Drops Vanilla Honey | MENTHOL | Cardinal Health 110, LLC. DBA Leader | 1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e2 | 2025-12-22 | Warnings | M012 |
Packages#
| 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 |