Mucinex
- Product NDC
- 17856-0008
- Requested package NDC
- 17856-0008-2
- 11-digit product format
- 178560008
- Labeler code
- 17856
- Product ID
- 17856-0008_45244b74-1b9b-2f5d-e063-6394a90a1002
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICAS CORP.
- Application
- NDA021282
- Marketing category
- NDA
- Marketing start
- 2012-07-03
- Substance
- GUAIFENESIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 17856-0008 | 17856-0008-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 17856-0008 | 17856-0008-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 17856-0008 | 17856-0008-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021282-001 | MUCINEX | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | |
| N021282-002 | MUCINEX | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021282-001 | 6372252 | 2020-04-28 | U-489 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021282-002 | 6372252 | 2020-04-28 | U-489 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021282-002 | 7838032 | 2020-04-28 | Drug product | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021282-001 | 6372252 | 2020-04-28 | U-489 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021282-002 | 6372252 | 2020-04-28 | U-489 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021282-002 | 7838032 | 2020-04-28 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021282-001 | 6372252 | 2020-04-28 | U-489 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021282-002 | 6372252 | 2020-04-28 | U-489 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021282-002 | 7838032 | 2020-04-28 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021282-001 | 6372252 | 2020-04-28 | U-489 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021282-002 | 6372252 | 2020-04-28 | U-489 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021282-002 | 7838032 | 2020-04-28 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021282-001 | 6372252 | 2020-04-28 | U-489 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021282-002 | 6372252 | 2020-04-28 | U-489 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021282-002 | 7838032 | 2020-04-28 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021282-001 | 6372252 | 2020-04-28 | U-489 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021282-002 | 6372252 | 2020-04-28 | U-489 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021282-002 | 7838032 | 2020-04-28 | Drug product | ea99ee380514… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mucinex
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 600 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 40c67cca-f202-4652-9507-2442d26cfd67 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-0008-2 | 2024-06-05 | C162847 | 48780-1 | f386c64a-1ccb-0266-e053-dadaa90a7c1a | Mucinex ® |
| 17856-0008-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1ccb-0266-e053-dadaa90a7c1a | Mucinex ® |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0008-2 | Mucinex | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-0008-2 | EA - Each | 17856-0008 | 891a875e-963b-4c51-822a-ce1dce4bc407 | 1 | 2025-06-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0008 | MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICAS CORP.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240606_40c67cca-f202-4652-9507-2442d26cfd67.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 636522 | guaiFENesin 600 MG 12HR Extended Release Oral Tablet | PSN | 40c67cca-f202-4652-9507-2442d26cfd67 | 9 |
| 891301 | Mucinex Expectorant 600 MG 12HR Extended Release Oral Tablet | PSN | 40c67cca-f202-4652-9507-2442d26cfd67 | 9 |
| 891301 | 12 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex] | SBD | 40c67cca-f202-4652-9507-2442d26cfd67 | 9 |
| 636522 | 12 HR guaifenesin 600 MG Extended Release Oral Tablet | SCD | 40c67cca-f202-4652-9507-2442d26cfd67 | 9 |
| 636522 | guaifenesin 600 MG 12 HR Extended Release Oral Tablet | SY | 40c67cca-f202-4652-9507-2442d26cfd67 | 9 |
| 891301 | Mucinex 600 MG 12 HR Extended Release Oral Tablet | SY | 40c67cca-f202-4652-9507-2442d26cfd67 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17856-0008-2 | 17856000802 | 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (17856-0008-2) | 2024-06-05 | 0000-00-00 | No | No | Current |