AXIV NightTime
- Product NDC
- 82706-016
- 11-digit product format
- 827060016
- Labeler code
- 82706
- Product ID
- 82706-016_3f047bdc-549e-c77b-e063-6394a90ae7ad
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- VIVUNT PHARMA LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-03-07
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 15; 6.25 mg/1; mg/1; mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- 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 | 82706-016 | 82706-016-02 | 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 | 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 NightTime
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1094549 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 131f6314-c9a1-7af3-e063-6294a90abe6f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82706-016-01 | AXIV NightTime | 3 in 1 CARTON | CAPSULE, LIQUID FILLED | 3 | 5 | |
| 82706-016-01 | AXIV NightTime | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 5 | |
| 82706-016-02 | AXIV NightTime | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 82706-016-02 | AXIV NightTime | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 82706-016-03 | AXIV NightTime | 50 in 1 CARTON | CAPSULE, LIQUID FILLED | 50 | 5 | |
| 82706-016-03 | AXIV NightTime | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 82706-016-04 | AXIV NightTime | 25 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 25 | 5 | |
| 82706-016-04 | AXIV NightTime | 25 in 1 CARTON | CAPSULE, LIQUID FILLED | 25 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82706-016 | AXIV NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [VIVUNT PHARMA LLC] | 4 | Current NDC, 8 package rows | 20250215_131f6314-c9a1-7af3-e063-6294a90abe6f.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 |
|---|---|---|---|---|---|---|
| Halls Honey Lemon | MENTHOL | Mondelez Global LLC | aec46410-ffb1-4db4-b232-82110c562f69 | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max DM Max | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 6a8cdcad-4881-49b8-a3f1-2c1574300d18 | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Chest Congestion Honey and Berry Flavor | GUAIFENESIN | Reckitt Benckiser LLC | 8ec74cf2-88f5-40be-87e2-b756ab841754 | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | c16253d3-3824-458c-8840-e3a2fbe7682c | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 1991d5ee-fc90-4070-8965-cd6f4abc45cf | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | a25278bd-c3b9-4db3-b4f7-b395eb5f9177 | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ba2cc08-acad-79a8-e063-6394a90af17f | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | a3523aa3-9ed1-472d-9986-438440d0a3eb | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2ed3c844-0532-40d9-beba-738d196de34d | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Sinus | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 6189fb89-a7d7-4ae6-a9e8-d9512acc0f55 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | a51b6312-598e-4a25-a873-6b59bc87d900 | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 1e243dbe-138f-4346-ba22-ceea01e97052 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | a14bc0d1-9b05-4a21-aaa8-95d4d073b9ed | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 128f3442-9802-4303-80be-aead09237936 | 2026-05-13 | Warnings | M012 |
| MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGY | OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | 41b8cead-92a0-47d8-8079-4fb5d18bf249 | 2026-05-13 | Warnings | M012 |
| Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 33f0d9bb-c67d-92ba-e063-6294a90a9943 | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain, Maximum Strength | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2c01962d-74e3-4dfa-b7cb-a91a687711d5 | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | f5365c6d-9296-41a5-953a-d1008954e67f | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8905706b-b9da-4520-8cf2-87d7c125edf3 | 2026-05-13 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 131f6314-c9a1-7af3-e063-6294a90abe6f | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 131f6314-c9a1-7af3-e063-6294a90abe6f | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 131f6314-c9a1-7af3-e063-6294a90abe6f | 5 |
| 2676954 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | 1320e243-344f-98ed-e063-6294a90a0092 | 2 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | 1320e243-344f-98ed-e063-6294a90a0092 | 2 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | PSN | 1320e243-344f-98ed-e063-6294a90a0092 | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 1320e243-344f-98ed-e063-6294a90a0092 | 2 |
| 1867684 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule | SCD | 1320e243-344f-98ed-e063-6294a90a0092 | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 1320e243-344f-98ed-e063-6294a90a0092 | 2 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | 1320e243-344f-98ed-e063-6294a90a0092 | 2 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | SY | 1320e243-344f-98ed-e063-6294a90a0092 | 2 |
| 1867684 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule | SY | 1320e243-344f-98ed-e063-6294a90a0092 | 2 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 1320e243-344f-98ed-e063-6294a90a0092 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82706-016-01 | 82706001601 | 3 BLISTER PACK in 1 CARTON (82706-016-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 3 blister pack | 2024-03-07 | No | No | Current |
| 82706-016-02 | 82706001602 | 2 in 1 POUCH | Historical | ||||
| 82706-016-03 | 82706001603 | 50 POUCH in 1 CARTON (82706-016-03) / 2 CAPSULE, LIQUID FILLED in 1 POUCH | 50 pouch | 2024-07-05 | No | No | Current |
| 82706-016-04 | 82706001604 | 25 BLISTER PACK in 1 CARTON (82706-016-04) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 25 blister pack | 2025-02-12 | No | No | Current |