Childrens Giltuss D
- Product NDC
- 58552-148
- 11-digit product format
- 585520148
- Labeler code
- 58552
- Product ID
- 58552-148_4aa0f801-6d78-eff0-e063-6294a90a0855
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Childrens Giltuss D
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Gil Pharmaceutical Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-11
- Substance
- CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 1.75; 5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- Childrens Giltuss D
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORPHENIRAMINE MALEATE | 1.75 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V1Q0O9OJ9Z | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cfc2493b-e99e-4b55-98a9-053f95d49844 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58552-148-04 | Childrens Giltuss D | 1 in 1 CARTON | SYRUP | 1 | 4 | |
| 58552-148-04 | Childrens Giltuss D | 1 in 1 BOTTLE | SYRUP | 1 | 4 |
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 |
|---|---|---|---|---|---|---|
| UP AND UP NO DRIP NASAL | OXYMETAZOLINE HYDROCHLORIDE | Target Corporation | 760d6d0f-00fc-40bc-858d-83a0827d139f | 2025-01-29 | Warnings | M012 |
| Guaifenesin and Dextromethorphan | GUAIFENESIN AND DEXTROMETHORPHAN | Major Pharmaceuticals | 51e48201-bb62-4e89-85eb-e4a416f93522 | 2025-01-29 | Warnings | M012 |
| Severe Congestion and Cough Max | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Best Choice | 8c878e47-94f4-484f-bdd8-6d87ac2440d8 | 2025-01-28 | Warnings | M012 |
| Cough and Cold Therapy | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Everlaan Organics Inc | 088be461-7afc-586a-e063-6294a90a700b | 2025-01-27 | Warnings | M012 |
| Cough and Cold Therapy For Kids | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Everlaan Organics Inc | 088df369-114c-db4f-e063-6394a90acfac | 2025-01-27 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a | 2025-01-26 | Warnings | M012 |
| Walgreens Menthol Cough Drops | MENTHOL | Walgreens | 2c62f690-8dfb-d28e-e063-6394a90a45a2 | 2025-01-23 | Warnings | M012 |
| Walgreens Cherry Cough Drops | MENTHOL | Walgreens | 2c65d836-e724-50d6-e063-6394a90a0827 | 2025-01-23 | Warnings | M012 |
| Walgreens Honey Lemon Cough Drops | MENTHOL | Walgreens | 2c67424c-2fb0-cc15-e063-6394a90a02ca | 2025-01-23 | Warnings | M012 |
| Pharmacys Prescription Analgesic Gel | MENTHOL | American Consumer Products Corp | 6f0725f2-833f-f3a0-e053-2a91aa0a3911 | 2025-01-23 | Warnings | M012 |
| Pharmacys Prescription Vapor Rub | MENTHOL | American Consumer Products Corp | 6ef328ff-f5c3-515d-e053-2a91aa0a32d3 | 2025-01-23 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Best Choice | 0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d | 2025-01-22 | Warnings | M012 |
| GOOD REMEDIES Allergy Relief SOFTGEL | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 26a02737-2cfd-769f-e063-6394a90af352 | 2025-01-22 | Warnings | M012 |
| Pharbechlor | CHLORPHENIRAMINE MALEATE 4MG | Ulai Health LLC | 6a1a5cef-e946-4ba8-9402-557c6adf45f9 | 2025-01-20 | Warnings | M012 |
| Pharbinex | GUAIFENESIN 400MG | Ulai Health LLC | 4eafa81a-aeee-4c97-85d6-594902b10919 | 2025-01-20 | M012 | |
| Pharbinex-PE | GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG | Ulai Health LLC | e459bb83-b1d6-42fc-aa46-99ad117e6144 | 2025-01-20 | M012 | |
| Pharbinex-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Ulai Health LLC | af80d10e-3fb2-405a-a803-1f876b8dcd10 | 2025-01-20 | M012 | |
| Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Bayer HealthCare LLC. | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a23a6db6-4585-2882-e053-2a95a90ab01a | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | fc754dff-cecd-fc6b-e053-6394a90ab371 | 2025-01-17 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58552-148-04 | 58552014804 | 1 BOTTLE in 1 CARTON (58552-148-04) / 1 SYRUP in 1 BOTTLE | 1 bottle | 2024-04-11 | No | No | Current |