WARNINGS
Do not use for children under 12 years of age
Do not use for children under 12 years of age
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 87448170102 | Guaifenesin ER 600mg Tablet_Label.jpg |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70010-199-05 | EA - Each | 70010-199 | dce956c0-6d27-41de-8ac1-f888d4d6e8f0 | 1 | 2022-09-12 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 87448-1701 | 87448-1701-2 |
| 70010-199 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213420-001 | GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | ||
| A213420-002 | GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| 51e1a5f5-577b-7f1e-e063-6394a90a00cb | 51e1a5f5-577a-7f1e-e063-6394a90a00cb | 2026-05-15 | Warnings | 51e1a5f5-577b-7f1e-e063-6394a90a00cb 51e1a5f5-577a-7f1e-e063-6394a90a00cb | ||
| GUAIFENESIN | GUAIFENESIN | GRANULES PHARMACEUTICALS INC. | e6994e38-2a21-4bcf-e053-2995a90a0854 | 2024-07-08 | Warnings | 70010-199 |
Adverse event summaries are temporarily unavailable. Other product information remains available.