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 | 2026-10-12 | |
| excluded package | package | 63824-201 | 63824-201-30 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 63824-201 | 63824-201-72 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|
| CVS Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | CVS PHARMACY, INC. | f4020c08-29f6-4609-834e-191ce6885130 | 2026-08-14 | Warnings | M012 |
| CVS Severe Cough, Flu Plus Sore Throat Honey | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | 95203001-7ca6-4513-83a3-9ef17855bc0f | 2026-08-14 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS PHARMACY | 81d26e9c-b713-4fb3-b0a5-68526bad230e | 2026-08-14 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 212acd54-6ff0-446a-a3bb-3b40e1279711 | 2026-08-13 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | e9d0b6f9-e9f3-431c-9f34-4d63108282a1 | 2026-08-13 | Warnings | M012 |
| Best Health Caramel Apple Cough Drops | MENTHOL | Bestco | 58eee9b4-d696-995f-e063-6294a90a5db0 | 2026-08-13 | Warnings | M012 |
| Best Health Pumpkin Spice Cough Drops | MENTHOL | Bestco | 58ef6619-9087-5f41-e063-6294a90a7da6 | 2026-08-13 | Warnings | M012 |
| Best Health Bourbon Honey Cough Drops | MENTHOL | Bestco | 58efdf29-83ea-03b9-e063-6294a90ad306 | 2026-08-13 | Warnings | M012 |
| daytime nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Amazon.com Services LLC | 9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e | 2026-08-13 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | 1e3c81b0-05de-4c4a-8579-f301f14626b3 | 2026-08-13 | Warnings | M012 |
| Tussin DM Daytime Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d59f6c64-8311-48ba-90d1-8000b04bfcda | 2026-08-13 | Warnings | M012 |
| TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT | ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 2026-08-12 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | f95220c5-e55c-4271-a267-d004ad2447bf | 2026-08-12 | Warnings | M012 |
| CVS PHARMACY Childrens Allergy Chews | DIPHENHYDRAMINE HCL | CVS PHARMACY, INC. | 569b8efa-8458-49f7-a665-6b7016a10505 | 2026-08-12 | Warnings | M012 |
| CVS PHARMACY DYE FREE Childrens Allergy Chews | DIPHENHYDRAMINE HCL | CVS PHARMACY, INC. | e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7 | 2026-08-12 | Warnings | M012 |
| Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | af35c833-316a-4d21-bd3a-9b71558cadbf | 2026-08-12 | Warnings | M012 |
| Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Wal-Mart Stores Inc | cc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c | 2026-08-11 | Warnings | M012 |
| Best Health Maple Spice Cough Drops | MENTHOL | Bestco | 58cfdacb-c713-220f-e063-6394a90acbfc | 2026-08-11 | Warnings | M012 |
| 7 Select Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | 7-ELEVEN | f9475972-0cbb-45c5-9e49-09569f1665a7 | 2026-08-11 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e3 | 2026-08-10 | 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 |