Supress DX Pediatric Drops
- Product NDC
- 52083-055
- Requested package NDC
- 52083-055-01
- 11-digit product format
- 520830055
- Labeler code
- 52083
- Product ID
- 52083-055_dc1e71f8-2a20-4968-b4ad-00c19b3d0dec
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- KRAMER NOVIS
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-03-29
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 5; 50; 2.5 mg/mL; mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 DX Pediatric Drops
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/mL |
| GUAIFENESIN | 50 mg/mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1095503 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ddb95436-7806-4086-af4d-18a6625b5c83 | 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 |
|---|---|---|---|---|---|---|
| 52083-055-01 | Supress DX Pediatric Drops | 30 mL in 1 BOTTLE | SYRUP | 30 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-055-01 | ML - Milliliter | 52083-055 | 3c236263-f16b-4deb-a0d6-5fbf7cf0a25e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52083-055 | SUPRESS DX PEDIATRIC DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241011_ddb95436-7806-4086-af4d-18a6625b5c83.zip |
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 |
|---|---|---|---|---|---|---|
| TUSICOF | DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE | Kramer Novis | e966b75c-4bb4-4216-8247-baada8f5d759 | 2025-11-12 | Warnings | M012 |
| Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 52327ed0-ea49-4d1c-b928-20ab381be9f2 | 2025-11-11 | Warnings | M012 |
| TOPCO Childrens Cough Relief | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Topco Associates, LLC | ee0f5627-5104-4990-88ee-2fb46965bc1e | 2025-11-11 | Warnings | M012 |
| TOPCARE Childrens Cold and Cough and Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates, LLC | 8931d4ca-c599-49be-87e1-8c0598f38b77 | 2025-11-11 | Warnings | M012 |
| TOPCARE Multi Symptom Flu Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Topco Associates, LLC | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2025-11-11 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 2025-11-11 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435e6387-1ee0-c20f-e063-6294a90adac5 | 2025-11-11 | Warnings | M012 |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | 10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b | 2025-11-10 | Warnings | M012 |
| TOPCARE Childrens Allergy Chews | DIPHENHYDRAMINE HCL | Topco Associates, LLC | b5e15dd1-6e99-411c-9183-8a4265eae404 | 2025-11-08 | Warnings | M012 |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | 103de130-ef12-4c58-bbcf-234b3f3b2cbf | 2025-11-08 | Warnings | M012 |
| Cough Drops Dollar General Strawberry 30ct | MENTHOL | Dollar General Corporation | 2b3fbab9-92b5-42a7-b27b-ff46350ce055 | 2025-11-07 | Warnings | M012 |
| Robitussin Day and Night Maximum Strength Cough DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 2025-11-07 | Warnings | M012 |
| Allergy plus Sinus Headache | ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG | Shield Pharmaceuticals Corp | 093649a4-f968-49bd-83af-bb7e0f448ecf | 2025-11-07 | Warnings | M012 |
| TARGET Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | TARGET CORPORATION | bfc91c71-0506-4e94-8bfe-dc9e4bf959da | 2025-11-07 | Warnings | M012 |
| CHILDRENS COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | H E B | 08f4785a-c628-4e9b-9412-b2a817f9be60 | 2025-11-07 | Warnings | M012 |
| G-TUSICOF | DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE | Kramer Novis | d169585f-b4f4-4831-8c71-e1533ae7e7c4 | 2025-11-07 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 1d512053-7a54-4691-a657-77da4c627cb8 | 2025-11-07 | Warnings | M012 |
| Allergy and Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dc249163-26dd-42ca-b423-2f16299f2d65 | 2025-11-07 | Warnings | M012 |
| Sinus Congestion | PSEUDOEPHEDRINE HCL | Chain Drug Marketing Association, Inc. | 9744d04d-298d-4acd-9470-db9e7f2901e7 | 2025-11-07 | Warnings | M012 |
| Daytime, Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 | 2025-11-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1095503 | dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution | PSN | ddb95436-7806-4086-af4d-18a6625b5c83 | 8 |
| 1095503 | dextromethorphan hydrobromide 5 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution | SCD | ddb95436-7806-4086-af4d-18a6625b5c83 | 8 |
| 1095503 | dextromethorphan HBr 5 MG / guaifenesin 50 MG / phenylephrine HCl 2.5 MG per 1 ML Oral Drops | SY | ddb95436-7806-4086-af4d-18a6625b5c83 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-055-01 | 52083005501 | 30 mL in 1 BOTTLE (52083-055-01) | 30 ml | 2011-03-29 | 0000-00-00 | No | No | Current |