mucus extended release
- Product NDC
- 51316-400
- Requested package NDC
- 51316-400-55
- 11-digit product format
- 513160400
- Labeler code
- 51316
- Product ID
- 51316-400_26d906cf-86ee-4c11-92e6-491b5ea405e7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- guaifenesin
- Dosage form
- TABLET, MULTILAYER, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- ANDA078912
- Marketing category
- ANDA
- Marketing start
- 2025-06-17
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078912-001 | GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | ||
| A078912-002 | GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078912-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-11-05 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078912-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2011-11-23 | bb7c543d1eb4… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- mucus extended release
- 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#
| Identifier | FDA.report destination |
|---|---|
| 310621 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9fcf96a7-bef4-4cc8-bd9e-c245ccbea17d | 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 |
|---|---|---|---|---|---|---|
| 51316-400-55 | mucus extended release | 6 in 1 CARTON | TABLET, MULTILAYER, EXTENDED REL | 6 | 2 | |
| 51316-400-55 | mucus extended release | 7 in 1 BLISTER PACK | TABLET, MULTILAYER, EXTENDED REL | 7 | 2 | |
| 51316-400-74 | mucus extended release | 2 in 1 CARTON | TABLET, MULTILAYER, EXTENDED REL | 2 | 2 | |
| 51316-400-74 | mucus extended release | 7 in 1 BLISTER PACK | TABLET, MULTILAYER, EXTENDED REL | 7 | 2 |
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 |
|---|---|---|---|---|---|---|
| Topcare Mucus ER | GUAIFENESIN | Topco Associates LLC | b787eac7-8f87-49a2-899b-5f524eb7b1fc | 2025-05-29 | Warnings | 078912 ANDA078912 |
| Guaifenesin Extended-Release | GUAIFENESIN | Precision Dose Inc. | 608b00c5-a2c7-4514-9b46-02954d6675d6 | 2025-05-27 | Warnings | 078912 ANDA078912 |
| Leader Mucus Relief | GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | 34981e01-f405-4feb-807b-3a8c02faca96 | 2025-03-09 | Warnings | 078912 ANDA078912 |
| Topcare mucus er | GUAIFENESIN | Topco Associates LLC | e3c900ad-21b1-4cd0-8c48-f54f115df403 | 2024-12-12 | Warnings | 078912 ANDA078912 |
| DG Health Mucus ER | GUAIFENESIN | Dolgencorp, LLC | bf99fa83-c3be-4052-b5b6-ad91997cb034 | 2023-04-06 | Warnings | 078912 ANDA078912 |
| mucus | GUAIFENESIN | CVS Pharmacy | d6f1889e-8228-4c8c-a0e9-6c2afdc07e99 | 2023-01-25 | Warnings | 078912 ANDA078912 |
| basic care mucus er | GUAIFENESIN | Amazon.com Services LLC | 14213a15-5842-456f-a5ab-654268c58f78 | 2022-04-11 | Warnings | 078912 ANDA078912 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310621 | guaiFENesin 1200 MG 12HR Extended Release Oral Tablet | PSN | 9fcf96a7-bef4-4cc8-bd9e-c245ccbea17d | 2 |
| 310621 | 12 HR guaifenesin 1200 MG Extended Release Oral Tablet | SCD | 9fcf96a7-bef4-4cc8-bd9e-c245ccbea17d | 2 |
| 310621 | guaifenesin 1200 MG 12 HR Extended Release Oral Tablet | SY | 9fcf96a7-bef4-4cc8-bd9e-c245ccbea17d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-400-55 | 51316040055 | 6 BLISTER PACK in 1 CARTON (51316-400-55) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | 6 blister pack | 2025-06-17 | No | No | Current |