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 | 2026-10-28 | |
| excluded package | package | 63824-201 | 63824-201-30 | D | Discontinued by firm | 2026-10-28 | |
| excluded package | package | 63824-201 | 63824-201-72 | D | Discontinued by firm | 2026-10-28 |
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 |
|---|---|---|---|---|---|---|
| NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Lil' Drug Store Products, Inc. | e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b | 2023-10-02 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | PD-Rx Pharmaceuticals, Inc. | ac8c0c15-b305-47f2-8712-e4b53636f7fa | 2023-10-02 | Warnings | M012 |
| Maximum strength Day cold and flu and Night severe cold and flu | ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS | TIME CAP LABORATORIES,INC | fff69901-965c-5372-e053-6394a90a29c2 | 2023-09-18 | Warnings | M012 |
| Tussin Mucus and Chest Congestion Sugar Free | GUAIFENESIN | AARNA USA, Inc. | 6e488782-0138-436d-a9f0-0ec5bc9daedd | 2023-05-15 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | KROGER COMPANY | 813b1db2-a177-77c6-e053-2a91aa0ac73b | 2023-01-17 | Warnings | M012 |
| MUCUS RELIEF DM | DEXTROMETHORPHAN HBR/GUAIFENESIN | KROGER COMPANY | 813baf42-edb0-33a9-e053-2a91aa0a8599 | 2023-01-17 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H-E-B | db19b8c7-0334-0664-e053-2a95a90ad61f | 2023-01-14 | Warnings | M012 |
| Nightime | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | H-E-B | db44560b-da02-74c9-e053-2a95a90af0b6 | 2023-01-13 | Warnings | M012 |
| DAYTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | dbf5656b-9105-871b-e053-2995a90a4941 | 2023-01-03 | Warnings | M012 |
| DAYTIME-NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | KROGER | a2508699-08c0-4a22-e053-2a95a90a8a6d | 2022-11-02 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | PAI Holdings, LLC dba PAI Pharma | c2e53fb5-2798-47c8-9285-d1077d46e629 | 2022-06-14 | Warnings | M012 |
| Mucus Relief DM | MUCUS RELIEF DM | TopCo Associates, LLC | 71674a9b-89ed-43d1-aadb-b9311fdfbdf9 | 2022-06-07 | Warnings | M012 |
| Daytime Nighttime Cold and Flu Relief Combo Pack | DAYTIME NIGHTTIME COLD AND FLU | Allegiant Health | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 2022-05-19 | Warnings | M012 |
| Mucus Relief DM Immediate Release | MUCUS RELIEF DM | Good Sense | 26a199bf-57e5-4f36-b40c-83a1187e4870 | 2022-05-18 | Warnings | M012 |
| Mucus Relief DM Immediate Release | MUCUS RELIEF DM | Allegiant Health | 731f8608-ad5b-491e-a4d4-2bb0c423fed5 | 2022-05-18 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b3c229a4-c772-70fb-e053-2a95a90a72db | 2022-03-11 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Good Sense | f88e2654-8e97-4cf6-9c36-01aeb51a9102 | 2021-11-30 | Warnings | M012 |
| Cold Medicine | COLD MEDICINE | Allegiant Health | 443fbc44-2c33-4316-ad31-dcc5a5aa8f52 | 2021-11-23 | Warnings | M012 |
| Decongestant PE Non Drowsy | PHENYLEPHRINE HCL | Allegiant Health | 7a3098b4-381c-4f32-97a7-87b53fd64428 | 2021-06-16 | Warnings | M012 |
| Mucus Relief Immediate Release | GUAIFENESIN 400MG | Good Sense | e7c68746-7ec0-46cf-b4a3-174fab819b5e | 2021-05-05 | 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 |