Mucinex Sinus-Max
- Product NDC
- 63824-201
- 11-digit product format
- 638240201
- Labeler code
- 63824
- Product ID
- 63824-201_51b4b925-d215-f58e-e063-6394a90a20a0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-07-23
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 200; 5 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
- 2027-12-31
- 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 | 63824-201 | 63824-201-20 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 63824-201 | 63824-201-30 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 63824-201 | 63824-201-72 | D | Discontinued by firm | 2026-10-23 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63824-201-20 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63824-201-72 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63824-201-30 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63824-201-20 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63824-201-72 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63824-201-30 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63824-201-20 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63824-201-72 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63824-201-30 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63824-201-20 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63824-201-72 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63824-201-30 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63824-201-20 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63824-201-72 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63824-201-30 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63824-201-20 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63824-201-72 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63824-201-30 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63824-201-20 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63824-201-72 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63824-201-30 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63824-201-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63824-201-72 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63824-201-30 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63824-201-20 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63824-201-72 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63824-201-30 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63824-201-20 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63824-201-72 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63824-201-30 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63824-201-20 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63824-201-72 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63824-201-30 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63824-201-20 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63824-201-72 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63824-201-30 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 63824-201-44 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 63824-201-20 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 63824-201-72 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 63824-201-30 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63824-201-44 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63824-201-20 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63824-201-72 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63824-201-30 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63824-201-44 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63824-201-20 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63824-201-72 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63824-201-30 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 63824-201-44 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 63824-201-20 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 63824-201-72 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 63824-201-30 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
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
- Mucinex Sinus-Max
- Brand name suffix
- Severe Congestion Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1243679 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 128f3442-9802-4303-80be-aead09237936 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 63824-201-20 | 2023-08-24 | Mucinex® Sinus-Max® Severe Congestion Relief |
| 63824-201-30 | 2023-08-24 | Mucinex® Sinus-Max® Severe Congestion Relief |
| 63824-201-44 | 2023-08-24 | Mucinex® Sinus-Max® Severe Congestion Relief |
| 63824-201-72 | 2023-08-24 | Mucinex® Sinus-Max® Severe Congestion Relief |
| 63824-201-20 | 2021-01-29 | Mucinex® Sinus-Max® Severe Congestion Relief |
| 63824-201-30 | 2021-01-29 | Mucinex® Sinus-Max® Severe Congestion Relief |
| 63824-201-44 | 2021-01-29 | Mucinex® Sinus-Max® Severe Congestion Relief |
| 63824-201-72 | 2021-01-29 | Mucinex® Sinus-Max® Severe Congestion Relief |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-201-20 | Mucinex Sinus-MaxSevere Congestion Relief | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 8 | |
| 63824-201-20 | Mucinex Sinus-MaxSevere Congestion Relief | 2 in 1 CARTON | TABLET, COATED | 2 | 8 | |
| 63824-201-30 | Mucinex Sinus-MaxSevere Congestion Relief | 3 in 1 CARTON | TABLET, COATED | 3 | 8 | |
| 63824-201-30 | Mucinex Sinus-MaxSevere Congestion Relief | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 8 | |
| 63824-201-44 | Mucinex Sinus-MaxSevere Congestion Relief | 4 in 1 CARTON | TABLET, COATED | 4 | 8 | |
| 63824-201-72 | Mucinex Sinus-MaxSevere Congestion Relief | 2 in 1 POUCH | TABLET, COATED | 2 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-201-20 | EA - Each | 63824-201 | d268a9c7-6a19-4a11-9bd1-8fab27c6a67c | 1 | 2013-07-02 |
| 63824-201-30 | EA - Each | 63824-201 | 77ca926f-85b6-4951-ac81-b108b894b207 | 1 | 2013-07-02 |
| 63824-201-44 | EA - Each | 63824-201 | d6348f78-8a80-4409-b828-b979e9e5c234 | 1 | 2015-08-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-201 | MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RB HEALTH (US) LLC] | 7 | Current NDC, Legacy NDC, 6 package rows | 20231130_128f3442-9802-4303-80be-aead09237936.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 |
|---|---|---|---|---|---|---|
| AXIV DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 131b1f17-cd86-f9b3-e063-6294a90a3028 | 2025-02-12 | Warnings | M012 |
| Maximum Strength Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Topco Associates, LLC | 17d0dbc7-c8c2-7917-e063-6394a90a42af | 2025-02-12 | Warnings | M012 |
| DAYTIME COLD AND FLU | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Kroger Company | bc00bbf8-52bb-fa75-e053-2a95a90a9406 | 2025-02-11 | Warnings | M012 |
| Daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELS | TIME CAP LABORATORIES, INC. | fd24653e-c4fa-3c09-e053-6394a90aaa9e | 2025-02-10 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELS | TIME CAP LABORATORIES INC. | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2025-02-10 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | DOLGENCORP, LLC | be2207b7-b8f8-7fba-e053-2a95a90abd16 | 2025-02-10 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE | Kroger Company | bc0115a3-5322-855d-e053-2995a90aba27 | 2025-02-10 | Warnings | M012 |
| Day time high blood pressure cold and flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR | Camber Consumer Care | 09fbd872-0970-4864-9308-4a7b85983920 | 2025-02-10 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f05e11ce-c908-acbc-e053-2a95a90a584e | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f035c499-cda6-fadf-e053-2995a90af457 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6d977ce-bbca-f1cc-e053-6394a90acc96 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6da36d3-496d-2336-e053-6394a90a0f83 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6da2e02-42c7-1ede-e053-6394a90aff5f | 2025-02-09 | Warnings | M012 |
| MUCOSA DM | GUAIFENESIN DEXTROMETHORPHAN | TIME CAP LABORATORIES, INC. | 62c1f4aa-6571-414c-9a58-31e107b7db97 | 2025-02-08 | Warnings | M012 |
| Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | 2d95d5a4-34dc-e195-e063-6394a90a39da | 2025-02-07 | Warnings | M012 |
| Halls Sugar Free Honey Lemon | MENTHOL | Mondelez Global LLC | 5d56ccd2-1c28-4750-9454-44809091ad2f | 2025-02-05 | Warnings | M012 |
| SanaTos Mucus Relief Cold Toddlers | DEXTROMETHORPHAN HBR, GUAIFENESIN | Pharmadel LLC | 60672feb-1421-651e-e053-2a91aa0af41d | 2025-02-04 | Warnings | M012 |
| SofSkin Vaporizing Chest Rub and Cough Suppressant | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Viny Health and Beauty Inc | 34626cf5-64fc-15c0-e063-6294a90aa310 | 2025-02-04 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS PHARMACY, INC | 17922df7-7867-4300-bd99-55aee7b60606 | 2025-02-04 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | f4b8ff54-47b5-4d18-bf4e-b101abb22a24 | 2025-02-03 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 128f3442-9802-4303-80be-aead09237936 | 8 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 128f3442-9802-4303-80be-aead09237936 | 8 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 128f3442-9802-4303-80be-aead09237936 | 8 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 128f3442-9802-4303-80be-aead09237936 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63824-201-20 | 63824020120 | 10 in 1 BLISTER PACK | Historical | ||||
| 63824-201-30 | 63824020130 | 3 in 1 CARTON | Historical | ||||
| 63824-201-44 | 63824020144 | 4 POUCH in 1 CARTON (63824-201-44) / 2 TABLET, COATED in 1 POUCH (63824-201-72) | 4 pouch | 2012-07-23 | No | No | Current |
| 63824-201-72 | 63824020172 | 2 in 1 POUCH | Historical |