SUPRESS-PE
- Product NDC
- 52083-056
- 11-digit product format
- 520830056
- Labeler code
- 52083
- Product ID
- 52083-056_e99c9cb7-48a2-4115-8c61-4f7a0a9942bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guiafenesin, Phenylephrine HCl
- Dosage form
- SOLUTION/ DROPS
- Route
- ORAL
- Labeler
- Kramer Novis
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-01-14
- Substance
- GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 50; 2.5 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52083-056-01 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52083-056-01 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52083-056-01 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52083-056-01 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52083-056-01 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52083-056-01 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52083-056-01 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- SUPRESS-PE
- Brand name suffix
- Pediatric
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 50 mg/mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 824600 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a474171d-5c29-4a80-9d37-00613796211a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 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 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52083-056-01 | 2025-04-22 | C162847 | 48780-1 | 2cef2736-b234-d83d-e063-dadaa90ab31f | SUPRESS ® PE PEDIATRIC DROPS |
| 52083-056-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b234-d83d-e063-dadaa90ab31f | SUPRESS ® PE PEDIATRIC DROPS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-056-01 | SUPRESS-PEPediatric | 30 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 30 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-056-01 | ML - Milliliter | 52083-056 | 64565411-aea5-49ec-874c-a8d98bf894b2 | 1 | 2014-02-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Black Cherry Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 856f2e1a-2593-99e6-e053-2991aa0ad039 | 2024-10-07 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 857363b6-e025-e074-e053-2a91aa0a4379 | 2024-10-07 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 857365ba-895e-4a63-e053-2991aa0a8b9f | 2024-10-07 | Warnings | M012 |
| Menthol Vapor Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | a7062db1-8201-b400-e053-2a95a90a55e8 | 2024-10-07 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Boston Nutraceutical Production SL | b8f48a47-6871-f7ed-e053-2995a90a16f3 | 2024-10-07 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 856f0bd8-354b-a002-e053-2a91aa0a8022 | 2024-10-07 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 83c4928a-eea6-e176-e053-2991aa0a6bb1 | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | c2340f56-9a8e-4eea-e053-2995a90a78fc | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | a706ee9c-9ed0-d3f1-e053-2a95a90a26d6 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff0b37b-6c08-b687-e053-2a95a90a11a9 | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Topco Associates LLC | efcf2edd-21a3-45f9-e053-2995a90a3865 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff65505-8846-35c2-e053-2a95a90a6b79 | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Topco Associates LLC | eff0fdfe-695a-4e62-e053-2a95a90ab50f | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff1a70f-fa71-52b2-e053-2995a90a038c | 2024-10-07 | Warnings | M012 |
| Honey Lemon Menthol Cough Drops | HONEY LEMON MENTHOL | Topco Associates LLC | f5be283b-524d-26af-e053-2995a90a3972 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff16ba3-7e30-aa93-e053-2995a90a64cb | 2024-10-07 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | ebf6bcf5-9384-052a-e053-2a95a90a30a5 | 2024-10-07 | Warnings | M012 |
| Rompe Pecho SF Flu SF Flu | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Efficient Laboratories Inc | 06eac696-e8f6-ac50-e063-6394a90a2ed6 | 2024-10-07 | Warnings | M012 |
| dg health nasal four | PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | ceeeb016-8e46-40b8-9923-8a4270475f45 | 2024-10-04 | Warnings | M012 |
| Topcare Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 99bc8829-167b-4cf8-8421-57da369f24cd | 2024-10-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 824600 | guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution | PSN | a474171d-5c29-4a80-9d37-00613796211a | 4 |
| 824600 | guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution | SCD | a474171d-5c29-4a80-9d37-00613796211a | 4 |
| 824600 | guaifenesin 50 MG / phenylephrine HCl 2.5 MG per 1 ML Oral Solution | SY | a474171d-5c29-4a80-9d37-00613796211a | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-056-01 | 52083005601 | 30 mL in 1 BOTTLE, DROPPER (52083-056-01) | 30 ml | 2014-01-14 | 0000-00-00 | No | No | Current |