Guaifenesin and Pseudoephedrine HCl
- Product NDC
- 51660-057
- 11-digit product format
- 516600057
- Labeler code
- 51660
- Product ID
- 51660-057_efb49ad2-ac54-4918-9c5a-7228a6dfa21c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Pseudoephedrine HCl
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ohm Laboratories, Inc.
- Application
- ANDA212542
- Marketing category
- ANDA
- Marketing start
- 2021-04-01
- Marketing end
- 0000-00-00
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE
- Active strength
- 1200 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 51660-057 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 51660-057 | 51660-057-12 | D | Discontinued by firm | 2026-08-03 |
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 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51660-057-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 51660-057-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 51660-057-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 51660-057-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 51660-057-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 51660-057-12 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 51660-057-12 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 51660-057-12 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 51660-057-12 | 0efc9e666f02… | f202fb6c5f17… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212542-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212542-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE / ORAL | 2020-04-28 | 87673890dc5c… |
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 | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51660-057-12 | 51660005712 | 1 BLISTER PACK in 1 CARTON (51660-057-12) > 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2021-04-01 | 0000-00-00 | No | No | Current |