Guaifenesin and Pseudoephedrine HCl
- Product NDC
- 0536-1488
- Requested package NDC
- 0536-1488-36
- 11-digit product format
- 005361488
- Labeler code
- 0536
- Product ID
- 0536-1488_5dbec3fa-0553-d9b1-e063-6394a90ac0d8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Pseudoephedrine HCl
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- RUGBY LABORATORIES, INC.
- Application
- ANDA212542
- Marketing category
- ANDA
- Marketing start
- 2026-10-12
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 600; 60 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | ||
| A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 4b0b4de00fa7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 D | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | RUGBY LABORATORIES, INC. | 997946e6-eff0-4c15-8694-020a19c2d336 | 2026-05-06 | Warnings | 212542 ANDA212542 |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Strategic Sourcing Services LLC | 27f85134-cd38-b33c-e063-6394a90a05a8 | 2024-11-28 | Warnings | 212542 ANDA212542 |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Ohm Laboratories, Inc. | 2521ecd3-28f3-a13c-e063-6394a90a7245 | 2024-10-23 | Warnings | 212542 ANDA212542 |
| MAXIMUM STRENGTH Mucus D | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | CVS Pharmacy | 9a560b80-972c-4af5-8fe8-eaef0b0d83b3 | 2022-12-01 | Warnings | 212542 ANDA212542 |
| Guaifenesin D | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | Walgreen Company | abecb791-b635-482f-bb99-3ee4b7093e78 | 2022-06-24 | Warnings | 212542 ANDA212542 |
| Guaifenesin D | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | CVS Pharmacy, Inc. | 4dee850b-b170-4ef9-ae02-3db9bfa05abe | 2022-06-08 | Warnings | 212542 ANDA212542 |
| Guaifenesin and Pseudoephedrine Hydrochloride | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | c857bcd9-6696-40d5-93c0-65097598cd4b | 2022-04-08 | Warnings | 212542 ANDA212542 |
| Guaifenesin and Pseudoephedrine Hydrochloride | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | d139fd8d-66fd-4484-8e78-ed90c505d999 | 2022-02-08 | Warnings | 212542 ANDA212542 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0536-1488-36 | 00536148836 | 2 BLISTER PACK in 1 CARTON (0536-1488-36) / 36 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2026-10-12 | No | No | Historical |