Guaifenesin 1200 mg
- Product NDC
- 43598-009
- 11-digit product format
- 435980009
- Labeler code
- 43598
- Product ID
- 43598-009_cdb94f95-f037-62cc-0d37-2b8c5ea26ca4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA215932
- Marketing category
- ANDA
- Marketing start
- 2022-03-15
- Substance
- GUAIFENESIN
- Active strength
- 1200 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
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 |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 43598-009 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-12 | ||
| unfinished package | package | 43598-009 | 43598-009-10 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-12 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 43598-009-10 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 43598-009-10 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 43598-009-10 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 43598-009-10 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 43598-009-10 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 43598-009-10 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 43598-009-10 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 43598-009-10 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 43598-009-10 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 43598-009-10 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 43598-009-10 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 43598-009-10 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 43598-009-10 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 43598-009-10 | 50b4072663b7… | eae3003ed65e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215932-001 | GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | ||
| A215932-002 | GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 |
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 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 5d02ea3f76ae… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215932-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215932-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2022-03-15 | a72a2bbeb626… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin 1200 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 1200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 99307c61-5df3-0a83-1e21-ddb03bc905b4 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43598-009-25 | Guaifenesin 1200 mg | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | 6 | |
| 43598-009-37 | Guaifenesin 1200 mg | 3 in 1 CARTON | TABLET, EXTENDED RELEASE | 3 | 6 | |
| 43598-009-74 | Guaifenesin 1200 mg | 14 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 14 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43598-009 | GUAIFENESIN 600 MG (GUAIFENESIN ) TABLET, EXTENDED RELEASE GUAIFENESIN 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240727_99307c61-5df3-0a83-1e21-ddb03bc905b4.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 |
|---|---|---|---|---|---|---|
| Guaifenesin 1200 mg | GUAIFENESIN | Dr. Reddy's Laboratories Inc. | 525fda90-134c-f038-c403-eb5ffc1fb1f1 | 2025-09-22 | Warnings | 215932 ANDA215932 |
| Guaifenesin 600 mg | GUAIFENESIN | CVS Pharmacy | ed242994-facd-750e-b7e1-2eec42c1f65f | 2024-11-11 | Warnings | 215932 ANDA215932 |
| Guaifenesin 600 mg | GUAIFENESIN | Strategic Sourcing Services, LLC | 469c5f00-1b6c-6fc7-a352-65764ff25d45 | 2024-11-09 | Warnings | 215932 ANDA215932 |
| Guaifenesin 600 mg | GUAIFENESIN | Dr. Reddy's Laboratories Inc. | 99307c61-5df3-0a83-1e21-ddb03bc905b4 | 2024-07-26 | Warnings | 215932 ANDA215932 43598-009 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310621 | guaiFENesin 1200 MG 12HR Extended Release Oral Tablet | PSN | 99307c61-5df3-0a83-1e21-ddb03bc905b4 | 6 |
| 636522 | guaiFENesin 600 MG 12HR Extended Release Oral Tablet | PSN | 99307c61-5df3-0a83-1e21-ddb03bc905b4 | 6 |
| 310621 | 12 HR guaifenesin 1200 MG Extended Release Oral Tablet | SCD | 99307c61-5df3-0a83-1e21-ddb03bc905b4 | 6 |
| 636522 | 12 HR guaifenesin 600 MG Extended Release Oral Tablet | SCD | 99307c61-5df3-0a83-1e21-ddb03bc905b4 | 6 |
| 310621 | guaifenesin 1200 MG 12 HR Extended Release Oral Tablet | SY | 99307c61-5df3-0a83-1e21-ddb03bc905b4 | 6 |
| 636522 | guaifenesin 600 MG 12 HR Extended Release Oral Tablet | SY | 99307c61-5df3-0a83-1e21-ddb03bc905b4 | 6 |
| 310621 | guaiFENesin 1200 MG 12HR Extended Release Oral Tablet | PSN | 525fda90-134c-f038-c403-eb5ffc1fb1f1 | 4 |
| 636522 | guaiFENesin 600 MG 12HR Extended Release Oral Tablet | PSN | 525fda90-134c-f038-c403-eb5ffc1fb1f1 | 4 |
| 310621 | 12 HR guaifenesin 1200 MG Extended Release Oral Tablet | SCD | 525fda90-134c-f038-c403-eb5ffc1fb1f1 | 4 |
| 636522 | 12 HR guaifenesin 600 MG Extended Release Oral Tablet | SCD | 525fda90-134c-f038-c403-eb5ffc1fb1f1 | 4 |
| 310621 | guaifenesin 1200 MG 12 HR Extended Release Oral Tablet | SY | 525fda90-134c-f038-c403-eb5ffc1fb1f1 | 4 |
| 636522 | guaifenesin 600 MG 12 HR Extended Release Oral Tablet | SY | 525fda90-134c-f038-c403-eb5ffc1fb1f1 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43598-009-10 | 43598000910 | 1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-009-10) | 15-MAR-22 | Current | ||||
| 43598-009-25 | 43598000925 | 2 BLISTER PACK in 1 CARTON (43598-009-25) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-009-74) | 2 blister pack | 2022-03-15 | 0000-00-00 | No | No | Current |
| 43598-009-37 | 43598000937 | 3 BLISTER PACK in 1 CARTON (43598-009-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-009-74) | 3 blister pack | 2022-09-01 | No | No | Current | |
| 43598-009-74 | 43598000974 | 14 in 1 BLISTER PACK | Historical |