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 | 2026-10-16 | ||
| excluded product | product | 67751-178 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 67751-178 | 67751-178-02 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 67751-178 | 67751-178-03 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 67751-178 | 67751-178-02 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 67751-178 | 67751-178-03 | D | Discontinued by firm | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| Pediacare Childrens Cough and Congestion Grape | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH | 9576723b-748c-45e7-bc0d-cc109b9f6735 | 2024-12-30 | Warnings | M012 |
| Cold and Flu Nighttime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Lil' Drug Store Products, Inc. | ef6836fa-d104-d7b3-e053-2a95a90af2b8 | 2024-12-30 | Warnings | M012 |
| Circle K Congestion Relief | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | 7e02fe57-f42f-4d3c-9002-4c4c0b1fafd6 | 2024-12-30 | Warnings | M012 |
| SDA Laboratories Tussin | GUAIFENESIN | SDA Laboratories, Inc. | 2a444cc8-96be-9432-e063-6394a90a1b63 | 2024-12-27 | Warnings | M012 |
| SDA Laboratories Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | SDA Laboratories, Inc. | 2a445f31-818d-11b1-e063-6294a90a8cb1 | 2024-12-27 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals Inc. | f184b2aa-91a4-44f9-b688-d4e318181984 | 2024-12-26 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals, Inc. | 2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | c7b1f980-9b0d-4f63-a70d-fd366658f863 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | 2ee2b332-9b85-45a6-b242-3f0ebfbd08a6 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | aebc7cf8-aaf7-4746-89f5-a64d0be1641e | 2024-12-26 | Warnings | M012 |
| Foster and Thrive Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | a1661a66-5e8c-4144-9c82-cbbcc75fb222 | 2024-12-23 | Warnings | M012 |
| Geri Dryl | DIPHENHYDRAMINE HCL | GERI-CARE PHARMACEUTICALS, CORP | 34d36146-6827-4800-8483-c0edb8f4cc28 | 2024-12-23 | Warnings | M012 |
| Guaiasorb DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 6299e352-116e-43f2-b40f-c704a7bd5d61 | 2024-12-23 | Warnings | M012 |
| Equaline Chest Congestion Relief | GUAIFENESIN | United Natural Foods, Inc. dba UNFI | ad9fde8b-10cd-4778-917d-1ed6b67e5ab1 | 2024-12-23 | Warnings | M012 |
| Equaline Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | United Natural Foods, Inc. dba UNFI | a40f5893-eb96-4e0e-b965-d78293c48dc9 | 2024-12-23 | Warnings | M012 |
| Tukol X-Pecto Miel Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | b9d32964-5bd7-44b0-be98-827d5310ed4f | 2024-12-20 | Warnings | M012 |
| Halls Honey Vanilla | MENTHOL | Mondelez Global LLC | 8e94a1b8-8915-4595-b097-8a0a319d54aa | 2024-12-20 | Warnings | M012 |
| Halls Sugar Free Mentho-Lyptus | MENTHOL | Mondelez Global LLC | 96046858-c57b-426e-8279-91b35e05bcdb | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, Best Choice | LEVMETAMFETAMINE | Valu Merchandisers Company | 3f1c086c-bc22-4abb-9921-565a13f30c20 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler | LEVMETAMFETAMINE NASAL DECONGESTANT | Walgreens | 77924474-ccc7-497b-9168-91490bcfadfc | 2024-12-20 | 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 |