AXIV Sinus Severe Mucus
- Product NDC
- 82706-020
- 11-digit product format
- 827060020
- Labeler code
- 82706
- Product ID
- 82706-020_3f04ea00-9815-32e5-e063-6294a90a14c6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, Phenylephrine Hydrocloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- VIVUNT PHARMA LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-03-08
- Substance
- PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN
- Active strength
- 5; 200; 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
- 2026-12-31
- Current FDA listing
- Yes
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 package | package | 82706-020 | 82706-020-02 | D | Discontinued by firm | 2026-10-27 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AXIV Sinus Severe Mucus
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| ACETAMINOPHEN | 325 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2049223 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 13245298-8b78-e177-e063-6294a90a6bec | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82706-020-01 | AXIV Sinus Severe Mucus | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 6 | |
| 82706-020-01 | AXIV Sinus Severe Mucus | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 6 | |
| 82706-020-02 | AXIV Sinus Severe Mucus | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 6 | |
| 82706-020-02 | AXIV Sinus Severe Mucus | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 6 | |
| 82706-020-03 | AXIV Sinus Severe Mucus | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 6 | |
| 82706-020-03 | AXIV Sinus Severe Mucus | 50 in 1 CARTON | CAPSULE, LIQUID FILLED | 50 | 6 | |
| 82706-020-04 | AXIV Sinus Severe Mucus | 25 in 1 POUCH | CAPSULE, LIQUID FILLED | 25 | 6 | |
| 82706-020-04 | AXIV Sinus Severe Mucus | 25 in 1 CARTON | CAPSULE, LIQUID FILLED | 25 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82706-020 | AXIV SINUS SEVERE MUCUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE) CAPSULE, LIQUID FILLED [VIVUNT PHARMA LLC] | 5 | Current NDC, 8 package rows | 20250215_13245298-8b78-e177-e063-6294a90a6bec.zip |
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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 832eb36c-21c6-46d7-b1f8-ab8b6f1e501e | 2024-10-22 | Warnings | M012 |
| Sinus plus Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter | c9d82968-b2ec-2f4b-e053-2a95a90a7f0c | 2024-10-22 | Warnings | M012 |
| Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter | b9d9ab99-44b1-455f-a29a-95c193a4808e | 2024-10-22 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HARRIS TEETER | b96c376e-578f-1124-e053-2a95a90acbb4 | 2024-10-22 | Warnings | M012 |
| Tukol Honey Daytime and Nighttime Value Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 2024-10-22 | Warnings | M012 |
| Cold Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter | c92b508b-e5f9-4149-8c4b-d21845943b3b | 2024-10-22 | Warnings | M012 |
| Cold Flu Severe Day Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter | 2924a691-b352-4263-b6ba-9ab97e95e2a5 | 2024-10-22 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HARRIS TEETER | b2091281-a64a-190a-e053-2995a90a890a | 2024-10-22 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | Safeway | cf04bdf7-fed4-4f06-a193-f2e83fcc531c | 2024-10-22 | Warnings | M012 |
| Tukol Honey Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | c9572b16-8e28-4f98-bd87-8a07721a49c6 | 2024-10-21 | Warnings | M012 |
| Tukol Honey Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | bf25f38e-3549-4f78-be90-46605b5f2c11 | 2024-10-21 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HEB | b5a6719e-746b-58ec-e053-2a95a90af010 | 2024-10-21 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | a6cdc084-c23b-e733-e053-2995a90a3506 | 2024-10-21 | Warnings | M012 |
| Cold Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | ea39a67d-8a99-4f7c-9925-94b07d0b1092 | 2024-10-21 | Warnings | M012 |
| Head Congestion plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | eb7920a3-3c25-6aa1-e053-2995a90ac2b9 | 2024-10-21 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | 9cbb3ab1-5f32-421e-9f28-d99be9447e9f | 2024-10-21 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | eb791902-e2c3-5662-e053-2995a90a37fd | 2024-10-21 | Warnings | M012 |
| Cold Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | c3849b66-697f-4f6e-93ab-76de031b3c70 | 2024-10-21 | Warnings | M012 |
| Cold Flu Severe Day Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | ee1477ed-00c4-46ea-bc57-aef214076dc2 | 2024-10-21 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTH | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | 774e8bee-1ab5-4587-82e4-31da8ec83544 | 2024-10-21 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2049223 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 13245298-8b78-e177-e063-6294a90a6bec | 6 |
| 2049223 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 13245298-8b78-e177-e063-6294a90a6bec | 6 |
| 2049223 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 13245298-8b78-e177-e063-6294a90a6bec | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82706-020-01 | 82706002001 | 2 BLISTER PACK in 1 CARTON (82706-020-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2024-03-08 | No | No | Current |
| 82706-020-02 | 82706002002 | 2 in 1 POUCH | Historical | ||||
| 82706-020-03 | 82706002003 | 50 POUCH in 1 CARTON (82706-020-03) / 2 CAPSULE, LIQUID FILLED in 1 POUCH | 50 pouch | 2024-07-05 | No | No | Current |
| 82706-020-04 | 82706002004 | 25 POUCH in 1 CARTON (82706-020-04) / 25 CAPSULE, LIQUID FILLED in 1 POUCH | 25 pouch | 2025-02-12 | No | No | Current |