Handy Solutions Cold Relief
- Product NDC
- 67751-177
- 11-digit product format
- 677510177
- Labeler code
- 67751
- Product ID
- 67751-177_f18a9208-274c-2f1f-e053-2995a90a5f30
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, 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
- 2024-01-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 | 67751-177 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 67751-177 | 67751-177-03 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 67751-177 | 67751-177-04 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 67751-177 | 67751-177-05 | D | Discontinued by firm | 2026-10-21 |
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 package | package | 67751-177-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 67751-177-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 67751-177-03 | 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 package | package | 67751-177-05 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 67751-177-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 67751-177-03 | 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 package | package | 67751-177-05 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 67751-177-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 67751-177-03 | 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 package | package | 67751-177-05 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 67751-177-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 67751-177-03 | 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 package | package | 67751-177-05 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 67751-177-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 67751-177-03 | 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 package | package | 67751-177-05 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 67751-177-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 67751-177-03 | 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 package | package | 67751-177-05 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 67751-177-04 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 67751-177-03 | 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 package | package | 67751-177-05 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 67751-177-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 67751-177-03 | 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 package | package | 67751-177-05 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 67751-177-04 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 67751-177-03 | 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 package | package | 67751-177-05 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 67751-177-04 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 67751-177-03 | 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 | 67751-177-05 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 67751-177-04 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 67751-177-03 | 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 | 67751-177-05 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 67751-177-04 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 67751-177-03 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|
| Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | DeMoulas Market Basket | e92d2f64-9690-42d3-b787-cafade3a8999 | 2023-12-29 | Warnings | M012 |
| Cold and Sinus Maxium Strength | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | 6e5ca8e1-5a03-4e77-b385-d44387fb3bfc | 2023-12-29 | Warnings | M012 |
| Cold, Flu and Sore Throat Maxium Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | d98029c0-ccd9-47e1-996f-c7786cd4ecca | 2023-12-29 | Warnings | M012 |
| MAXIMUM STRENGTH Sinus Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 0f2be061-bd0a-4e62-b994-6d0768ea647a | 2023-12-29 | Warnings | M012 |
| Tussin CF Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | c19b9997-4037-48f3-b905-86da421a292d | 2023-12-29 | Warnings | M012 |
| HempNesic | MENTHOL, CAMPHOR | Blaine Labs Inc. | 0239ada0-644d-4ef4-a3b8-df70246a3bc2 | 2023-12-21 | Warnings | M012 |
| HempNesic | MENTHOL, CAMPHOR | Blaine Labs Inc. | a698502d-c1c5-41ca-8142-74338b834c8b | 2023-12-21 | Warnings | M012 |
| Father Johns Cough Medicine Plus | NASAL DECONGESTANT | Oakhurst Company | 8b8aab0f-251b-6bd8-e053-2995a90ad748 | 2023-12-18 | Warnings | M012 |
| Father Johns Medicine | DEXTROMETHORPHAN HBR | Oakhurst Company | 8b8a249d-55af-cc98-e053-2995a90a431d | 2023-12-18 | Warnings | M012 |
| Daytime Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATED | Lil' Drug Store Products, Inc. | e79d92d2-d73c-d44f-e053-2995a90a03d9 | 2023-12-15 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL TABLET | Lil' Drug Store Products, Inc. | e5339c39-1d66-b283-e053-2995a90a4317 | 2023-12-15 | Warnings | M012 |
| Father Johns Medicine | DEXTROMETHORPHAN HBR | Humco Holding Group, Inc | a7b0669f-8da1-5a44-e053-2995a90a84d9 | 2023-12-15 | Warnings | M012 |
| Ephedrine Hydrochloride | EPHEDRINE HYDROCHLORIDE | Walgreen Company | bcb81dc1-d854-30c0-e053-2a95a90a9fc7 | 2023-12-14 | Warnings | M012 |
| Allergy, Circle K | DIPHENHYDRAMINE HCL 25MG TABLET | Lil' Drug Store Products, Inc. | d1f370ac-e7f4-baf7-e053-2995a90a1e50 | 2023-12-14 | Warnings | M012 |
| Circle K Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | a6a1e3d9-575c-4adf-beb6-c9719de55c67 | 2023-12-14 | Warnings | M012 |
| Non-Drowsy Sinus Severe, Circle K | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED | Lil' Drug Store products, Inc. | e78c456f-f62e-596d-e053-2995a90a2397 | 2023-12-14 | Warnings | M012 |
| Non-Drowsy Max Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATED | Lil' Drug Store Products, Inc. | e79f1a92-d8ea-e3f9-e053-2a95a90a2d37 | 2023-12-14 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Major Pharmaceuticals | bcc1a001-4176-485d-aaf0-2037ca65c6b8 | 2023-12-14 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Major Pharmaceuticals | edb49b17-06a7-4c25-bc7c-d62c1deac7f1 | 2023-12-13 | Warnings | M012 |
| Family Wellness Oxymetazoline No Drip | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 0c006b1c-8ab2-4b9c-8738-e7001c1bb47d | 2023-12-11 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67751-177-03 | 67751017703 | 2 TABLET in 1 POUCH (67751-177-03) | 2 tablet | 2016-10-22 | 0000-00-00 | No | No | Current |
| 67751-177-04 | 67751017704 | 1 POUCH in 1 CARTON (67751-177-04) > 2 TABLET in 1 POUCH | 1 pouch | 2016-10-22 | 0000-00-00 | No | No | Current |
| 67751-177-05 | 67751017705 | 3 POUCH in 1 CARTON (67751-177-05) > 2 TABLET in 1 POUCH | 3 pouch | 2016-10-22 | 0000-00-00 | No | No | Current |