Pharbinex-DM
- Product NDC
- 73057-381
- 11-digit product format
- 730570381
- Labeler code
- 73057
- Product ID
- 73057-381_2c2a50d1-d024-3c0f-e063-6394a90a13cc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin 400mg and Dextromethorphan HBr 20mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ulai Health LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-07-18
- Substance
- GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 400; 20 mg/1; mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- 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 | 73057-381-04 | 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 | 73057-381-04 | 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-DM
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 400 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1147685 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| af80d10e-3fb2-405a-a803-1f876b8dcd10 | 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73057-381-04 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-5068-a426-e053-dadaa90af4c2 | Drug Facts |
| 73057-381-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5068-a426-e053-dadaa90af4c2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73057-381-04 | Pharbinex-DM | 30 in 1 BOTTLE, PLASTIC | TABLET | 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 |
|---|---|---|---|---|---|---|
| Menthol Cough Drops Honey Vanilla Flavor | MENTHOL | 7-ELEVEN | 2f3c43dd-175f-722e-e063-6294a90acff9 | 2025-02-28 | Warnings | M012 |
| Menthol Cough Drops Creamy Strawberry Flavor | MENTHOL AND PECTIN | 7-ELEVEN | 2f3c3c65-4178-6304-e063-6294a90a51fa | 2025-02-28 | Warnings | M012 |
| Menthol Cough Drops Creamy Strawberry Flavor | MENTHOL AND PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2efbffd7-bbdd-c5f5-e063-6294a90a15f0 | 2025-02-25 | Warnings | M012 |
| Menthol Cough Drops Honey Vanilla Flavor | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2efc46c9-a421-1998-e063-6394a90aeb64 | 2025-02-25 | Warnings | M012 |
| Redicare Cough Drops Cherry Flavored | CHERRY FLAVORED MENTHOL COUGH DROPS | Redicare LLC | 2efeaafa-ee96-37ee-e063-6394a90a9a4b | 2025-02-25 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | Genexa Inc. | e880b8d7-61c3-41cc-e053-2995a90aaaeb | 2025-02-20 | Warnings | M012 |
| Gencare-Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | 596ec923-56a0-4b6e-a69c-8d740feb75a2 | 2025-02-20 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 77a2dc96-73ee-4ca2-b1fe-406995802606 | 2025-02-19 | Warnings | M012 |
| nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2 | 2025-02-19 | Warnings | M012 |
| Coricidin HBP Cold and Flu | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | Bayer HealthCare LLC. | 763a5334-a741-4678-9947-603776622450 | 2025-02-18 | Warnings | M012 |
| Sof Skin Vaporizing Chest Rub and Cough Suppressant | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Viny Health and Beauty Inc | 46ae16a4-b8a7-44de-ae1a-9bb503c15ea0 | 2025-02-18 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 4897d1df-4fb3-46e2-bbf0-847e964dca0a | 2025-02-18 | Warnings | M012 |
| meijer EXTRA STRENGTH Pain Relief PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 1bee7e4f-1813-1bdf-e063-6294a90a6a32 | 2025-02-17 | Warnings | M012 |
| ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL | Kroger Company | a24f09d9-60f1-853a-e053-2a95a90ae1fa | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGTH COLD AND FLU | ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | FAMILY DOLLAR SERVICES | a7343bea-53cc-4621-e053-2a95a90a2a5f | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGHT DAY COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8ebccf-6813-2dca-e053-2a95a90a032b | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8f0465-1595-0b0f-e053-2a95a90a0081 | 2025-02-15 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | KROGER COMPANY | 9bb7aaf0-6698-9a5c-e053-2a95a90a097c | 2025-02-14 | Warnings | M012 |
| Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H-E-B | db432947-fe02-79b2-e053-2a95a90af4a9 | 2025-02-14 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1147685 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Tablet | PSN | af80d10e-3fb2-405a-a803-1f876b8dcd10 | 3 |
| 1147685 | dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet | SCD | af80d10e-3fb2-405a-a803-1f876b8dcd10 | 3 |
| 1147685 | guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet | SY | af80d10e-3fb2-405a-a803-1f876b8dcd10 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 73057-381-04 | 73057038104 | 30 TABLET in 1 BOTTLE, PLASTIC (73057-381-04) | 30 tablet | 2019-07-18 | 0000-00-00 | No | No | Current |