Supress DX Pediatric Drops
- Product NDC
- 52083-055
- 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 |
|---|---|---|---|---|---|---|
| sinus pressure and pain pe | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a7931e4c-8a5e-66e2-e053-2995a90af2a4 | 2024-10-18 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 570ea130-6a99-446e-9f97-14fc95809006 | 2024-10-18 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a14999e3-a9d9-0a1f-e053-2995a90af7b3 | 2024-10-18 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a793000b-3ef9-5662-e053-2a95a90ad0da | 2024-10-18 | Warnings | M012 |
| Cold Multi-Symptom Daytime and Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 37455f86-ab21-472b-9e80-40324699f3ca | 2024-10-18 | Warnings | M012 |
| Head Congestion Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | e3396a27-8643-71fa-e053-2a95a90a713d | 2024-10-18 | Warnings | M012 |
| Head Congestion Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | e3397f69-3267-ca0b-e053-2995a90a7db5 | 2024-10-18 | Warnings | M012 |
| Cold and Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 747512a2-3b6d-496b-ab80-819060314163 | 2024-10-18 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | AMERISOURCE BERGEN | 9daf7f40-d9c5-4367-be41-894208358fc1 | 2024-10-18 | Warnings | M012 |
| Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 608e6808-29e4-40bc-8496-24c092681a1b | 2024-10-18 | Warnings | M012 |
| Cold Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 665db127-ee04-46c4-bff0-e0fe9950c3e2 | 2024-10-18 | Warnings | M012 |
| Cold Max Day and Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 87a1cc06-9994-4fa9-8c64-e2ffdd33a2f8 | 2024-10-18 | Warnings | M012 |
| Cold Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 604d7e53-4bfd-4cdd-aed2-b304ae82ce44 | 2024-10-18 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | DISCOUNT DRUG MART | 4d93a703-c905-4fb3-b772-11c207065d4d | 2024-10-17 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 62c35320-87b5-46e2-9f6f-cb0882bdb52e | 2024-10-17 | Warnings | M012 |
| Cold Max Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e3dcf6cf-373c-ea83-e053-2a95a90ae57a | 2024-10-17 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a7e99dad-5918-6a90-e053-2a95a90a8803 | 2024-10-17 | Warnings | M012 |
| SINUS AND HEADACHE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a7e99dad-5916-6a90-e053-2a95a90a8803 | 2024-10-17 | Warnings | M012 |
| ALLERGY MULTISYMPTOM | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a7e9ab8e-2252-180d-e053-2a95a90a788f | 2024-10-17 | Warnings | M012 |
| COLD PLUS HEAD CONGESTION SEVERE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 3430c7e4-e142-407e-bed5-358dd6bd10f7 | 2024-10-17 | 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 |