Childrens Robitussin Cough and Cold CF
- Product NDC
- 0031-8716
- 11-digit product format
- 000318716
- Labeler code
- 0031
- Product ID
- 0031-8716_13de3a9e-573f-846a-e063-6294a90a53c9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M001
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-09-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 5; 50; 2.5 mg/5mL; mg/5mL; mg/5mL
- 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
- 2026-12-31
- 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 Robitussin Cough and Cold CF
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
| GUAIFENESIN | 50 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/5mL |
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 |
|---|---|
| 1370205 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fcd0a8e0-ac2a-039a-be3c-534195d6bcfd | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0031-8716-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-322c-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0031-8716-12 | Childrens Robitussin Cough and Cold CF | 118 mL in 1 BOTTLE | LIQUID | 118 | 11 | |
| 0031-8716-12 | Childrens Robitussin Cough and Cold CF | 1 in 1 CARTON | LIQUID | 1 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0031-8716-12 | ML - Milliliter | 0031-8716 | 9013f2a7-98f7-4ea4-8376-e274dde56d26 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0031-8716 | CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [HALEON US HOLDINGS LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240318_fcd0a8e0-ac2a-039a-be3c-534195d6bcfd.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 |
|---|---|---|---|---|---|---|
| Heartburn and gas fruit chews | CALCIUM CARBONATE | CVS Pharmacy | 4a656a9f-8f34-69b7-e054-00144ff8d46c | 2025-12-07 | Warnings | M001 |
| Orange Antacid Soft Chew | CALCIUM CARBONATE | CVS Pharmacy | 4a67f0d0-788b-433b-e054-00144ff88e88 | 2025-12-07 | Warnings | M001 |
| Cherry Antacid Soft Chews | CALCIUM CARBONATE | CVS Pharmacy | 61e4e83c-ee98-579d-e053-2991aa0ab099 | 2025-12-07 | Warnings | M001 |
| CVS Mixed Berry Antacid HBG 54ct | CALCIUM CARBONATE | CVS Pharmacy | e9204edb-e4d9-3975-e053-2995a90ac6a9 | 2025-12-07 | Warnings | M001 |
| CVS Mixed Berry Antacid HBG 28ct | CALCIUM CARBONATE | CVS Pharmacy | e9481d36-3b28-5caf-e053-2a95a90a3121 | 2025-12-07 | Warnings | M001 |
| CVS Wild Berry Antacid Chews | CALCIUM CARBONATE | CVS Pharmacy | f6f45d9c-f9fc-225b-e053-6394a90a30e1 | 2025-12-07 | Warnings | M001 |
| CVS Wild Berry Antacid Chews | CALCIUM CARBONATE | CVS Pharmacy | f6f5dc9a-b573-70c1-e053-6394a90acdb0 | 2025-12-07 | Warnings | M001 |
| Basic Care Antacid Fruit Chews | CALCIUM CARBONATE | Amazon.com | c8d2b8aa-fce4-f973-e053-2995a90a6edd | 2025-12-05 | Warnings | M001 |
| Basic Care Berry Antacid HBG | CALCIUM CARBONATE | Amazon.com | c8d4050e-75fd-2445-e053-2995a90a7b0d | 2025-12-05 | Warnings | M001 |
| QUALITY CHOICE Regular Strength | ANTACID TABLETS (CALCIUM CARBONATE) | QUALITY CHOICE (Chain drug Marketing Assoiciation) | fce6c50d-908f-44a6-ba63-ece813f3711b | 2025-12-04 | Warnings | M001 |
| QUALITY CHOICE Regular Strength | ANTACID TABLETS (CALCIUM CARBONATE) | QUALITY CHOICE (Chain drug Marketing Assoiciation) | 667ffb59-9bff-45a7-89f0-ccfa0d841909 | 2025-12-04 | Warnings | M001 |
| QUALITY CHOICE | CALCIUM CARBONATE | QUALITY CHOICE (Chain drug Marketing Assoiciation) | 9ff282fd-7623-4c9e-8faa-c51e33a7616e | 2025-12-04 | Warnings | M001 |
| QUALITY CHOICE Extra Strength | ANTACID TABLETS (CALCIUM CARBONATE) | QUALITY CHOICE (Chain drug Marketing Assoiciation) | 7c948dc6-e569-46d2-8edd-59da48857e0e | 2025-12-04 | Warnings | M001 |
| QUALITY CHOICE Ultra Strength | ANTACID TABLETS (CALCIUM CARBONATE) | QUALITY CHOICE (Chain drug Marketing Assoiciation) | b074a885-5d10-46e4-8de9-dd9460968dad | 2025-12-04 | Warnings | M001 |
| Quality Choice Extra Strength | ANTACID TABLETS (CALCIUM CARBONATE) | QUALITY CHOICE (Chain drug Marketing Assoiciation) | 2bb8ccb6-6275-4ace-8096-ee545501df39 | 2025-12-04 | Warnings | M001 |
| Quality Choice Ultra Strength | ANTACID TABLET (CALCIUM CARBONATE) | QUALITY CHOICE (Chain drug Marketing Assoiciation) | cdac56f1-e579-4943-a24a-6564c30086d2 | 2025-12-04 | Warnings | M001 |
| QUALITY CHOICE Original Flavor | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | CHAIN DRUG MARKETING ASSOCIATION INC. | a699b830-6400-4af9-9810-5eda79157333 | 2025-12-04 | Warnings | M001 |
| Alka-Seltzer Heartburn Relief Peppermint | CALCIUM CARBONATE | Bayer HealthCare LLC. | 9b8e802f-91b6-4559-e053-2a95a90aff67 | 2025-12-04 | Warnings | M001 |
| Alka-Seltzer Cool Action Heartburn Relief Mint | CALCIUM CARBONATE | Bayer HealthCare LLC. | 9b8da147-8d0c-e6b0-e053-2a95a90a35e6 | 2025-12-04 | Warnings | M001 |
| Alka-Seltzer Kids Tummy ReliefChews | CALCIUM CARBONATE AND DIMETHICONE | Bayer HealthCare LLC. | ba48966e-3762-5fdf-e053-2995a90aeb3d | 2025-12-04 | Warnings | M001 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1370205 | dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | fcd0a8e0-ac2a-039a-be3c-534195d6bcfd | 11 |
| 1370205 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | fcd0a8e0-ac2a-039a-be3c-534195d6bcfd | 11 |
| 1370205 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | fcd0a8e0-ac2a-039a-be3c-534195d6bcfd | 11 |
| 1370205 | dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution | SY | fcd0a8e0-ac2a-039a-be3c-534195d6bcfd | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0031-8716-12 | 00031871612 | 1 BOTTLE in 1 CARTON (0031-8716-12) / 118 mL in 1 BOTTLE | 1 bottle | 2009-09-01 | 0000-00-00 | No | No | Current |