Pharbinex-PE
- Product NDC
- 73057-389
- 11-digit product format
- 730570389
- Labeler code
- 73057
- Product ID
- 73057-389_2c2a2804-8a2b-be5d-e063-6394a90a9763
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GUAIFENESIN 400mg and PHENYLEPHRINE HCL 10MG
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Ulai Health LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-07-18
- Substance
- GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 400; 10 mg/1; mg/1
- 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
- 2026-12-31
- 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 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 | 73057-389-04 | 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 | 73057-389-04 | 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
- Pharbinex-PE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 400 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1304111 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e459bb83-b1d6-42fc-aa46-99ad117e6144 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73057-389-04 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-9ec4-a426-e053-dadaa90af4c2 | Drug Facts |
| 73057-389-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9ec4-a426-e053-dadaa90af4c2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73057-389-04 | Pharbinex-PE | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | 3 |
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 |
|---|---|---|---|---|---|---|
| Kids Allergy | DIPHENHYDRAMINE HCL | Genexa Inc. | a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec4 | 2026-05-08 | Warnings | M012 |
| day time non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | f4fd597f-bca2-4ed4-b353-6c734f2f885c | 2026-05-08 | Warnings | M012 |
| Daytime Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | d8339bb0-5da3-4f34-a819-339643cf4a97 | 2026-05-08 | Warnings | M012 |
| severe tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | a26afc33-533e-4dc0-ab25-21be87356e22 | 2026-05-08 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | cdd53eba-1fa2-49c1-b03d-c32f309da7fb | 2026-05-08 | Warnings | M012 |
| Benadryl Allergy Liqui-Gels | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | bfeae100-e2d1-4607-be3b-2d9b15cd4f7f | 2026-05-07 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | H E B | 6503761f-37ae-4f39-b727-cb75d4c4a3c9 | 2026-05-07 | Warnings, Adverse reactions | M012 |
| Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOPCO ASSOCIATES LLC | ad199488-a4be-4b6e-b806-67ce8a6e907e | 2026-05-07 | Warnings | M012 |
| good sense nasal | OXYMETAZOLINE HCL | L. Perrigo Company | 5d42adb9-3625-4072-a6b1-29a229f255c8 | 2026-05-07 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 4856cd7b-ccdf-4546-9c65-236ebaac3dca | 2026-05-06 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac | 2026-05-06 | Warnings | M012 |
| daytime cough and chest congestion dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 175cc2d0-0202-4e38-8af2-9fc126b7412d | 2026-05-06 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 90fae0fa-da07-4ea8-bdbd-39c2ed99ae59 | 2026-05-06 | Warnings | M012 |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 5d8b980f-0011-41e3-a881-ad10fe399079 | 2026-05-06 | Warnings | M012 |
| HALLS Mentholyptus | MENTHOL | Mondelez Global LLC | 38d12374-e2c7-444c-e063-6294a90a42b3 | 2026-05-06 | Warnings | M012 |
| HALLS Mentholyptus | MENTHOL | Mondelez Global LLC | 1ab295ff-94b1-c938-e063-6294a90a98fd | 2026-05-06 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 512af63d-2f09-4baa-e063-6394a90a86bd | 2026-05-06 | Warnings | M012 |
| Thieves Chest Rub | CHEST RUB | Young Living Essential Oils, LC. | 9b7f125e-6caa-c53e-e053-2a95a90a737e | 2026-05-06 | Warnings | M012 |
| Maximum Strength Mucus Relief Plus Pain and Headache | ACETAMINOPHEN, GUAIFENESIN | Shield Pharmaceuticals Corp | f20c0db1-dcf3-4bfc-b3e4-930398f82dc9 | 2026-05-06 | Warnings | M012 |
| Nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | 8aa6492b-1723-4c6b-82ee-4f800301c6ad | 2026-05-06 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1304111 | guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet | PSN | e459bb83-b1d6-42fc-aa46-99ad117e6144 | 3 |
| 1304111 | guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SCD | e459bb83-b1d6-42fc-aa46-99ad117e6144 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 73057-389-04 | 73057038904 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (73057-389-04) | 2019-07-18 | 0000-00-00 | No | No | Current |