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 |
|---|---|---|---|---|---|---|
| FEVIA Acid Control | CALCIUM CARBONATE | VIVUNT PHARMA LLC | 4d695a90-6502-3020-e063-6394a90ab0c3 | 2026-07-15 | Warnings | M001 |
| GOOD NEIGHBOR PHARMACY Antacid Extra Strength | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | Amerisource Bergen | 5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f | 2026-07-13 | Warnings | M001 |
| Major Regular Strength Assorted Flavors | ANTACID TABLETS | Major Pharmaceuticals | 2ba0eeb2-7048-4259-83d5-9f4ec1c92d32 | 2026-07-13 | Warnings | M001 |
| Good Neighbor Extra Strength Assorted Fruits | CALCIUM CARBONATE | AMERISOURCE BERGEN | abf564a1-0823-433d-a023-8be4e085daf4 | 2026-07-13 | Warnings | M001 |
| Omeprazole, 24/7 Life by 7-Eleven | OMEPRAZOLE TABLET, DELAYED RELEASE | Lil' Drug Store Products, Inc. | 36d8a272-6cca-e759-e063-6394a90a9df8 | 2026-07-08 | Warnings | M001 |
| Tums Ultra | CALCIUM CARBONATE | Haleon US Holdings LLC | c544120f-15f0-48b5-88b2-d4820f180f50 | 2026-07-07 | Warnings | M001 |
| Regular Strength Assorted Flavors | ANTACID CALCIUM CARBONATE | AKRON PHARMA INC | 3f7fe022-aee9-b899-e063-6394a90afb4e | 2026-07-07 | Warnings | M001 |
| Magnesium Oxide | MAGNESIUM OXIDE | Westminster Pharmaceuticals, LLC | 52eeac0e-94bb-48c3-81dc-578e96406c01 | 2026-07-06 | Warnings | M001 |
| Kids Tummy Relief | CALCIUM CARBONATE | PNP Pharmaceuticals Inc. | 5103a317-5c4a-ec96-e063-6294a90aad7e | 2026-07-01 | Warnings | M001 |
| Childrens Antacid | CALCIUM CARBONATE | DOLGENCORP, LLC | 4d6ebc7e-ef39-47e8-91e9-f38484329fa9 | 2026-06-30 | Warnings | M001 |
| Ultra Strength Antacid | CALCIUM CARBONATE CHEWABLE TABLETS | CVS Pharmacy. Inc. | 24cec2bc-cf12-b513-e063-6394a90a9447 | 2026-06-30 | Warnings | M001 |
| Childrens Stomach Relief | CALCIUM CARBONATE | Chain Drug Marketing Association, Inc. | fb47d693-72d7-4586-9855-5e833ad1406f | 2026-06-18 | Warnings | M001 |
| Dr. Sana Alivio Digestivo UPSET STOMACH | EFEFERVESCENT ANTACID | EVI LABS | 51b8750c-3fcf-2543-e063-6394a90a7a8f | 2026-06-16 | Warnings | M001 |
| E-Z-GAS II | ANTACID/ANTIFLATULENT | E-Z-EM, INC. | 4e12e1cb-b033-076d-e054-00144ff8d46c | 2026-06-15 | Warnings | M001 |
| Sodium Bicarbonate | SODIUM BICARBONATE | Cardinal Health 107, LLC | 60c2a176-8854-4479-b853-d07fe9a1830c | 2026-06-12 | Warnings | M001 |
| Mag-Al Plus | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | Cardinal Health 107, LLC | 08df7403-9ee3-4a43-a151-c1a6ef7a7549 | 2026-06-10 | Warnings | M001 |
| Childrens Antacid | CALCIUM CARBONATE | Rite Aid Corporation | d09c2d99-9a1f-4eae-a048-ab6dbf74a798 | 2026-06-09 | Warnings | M001 |
| Maximum Strength Calcium Carbonate 1000mg | CALCIUM CARBONATE CHEWABLE TABLETS | CVS HEALTH CORP | 24ce4597-b571-3cbf-e063-6394a90a8ea2 | 2026-06-09 | Warnings | M001 |
| Tums Chewy Bites with Gas Relief | CALCIUM CARBONATE AND SIMETHICONE | Haleon US Holdings LLC | 6d7be7e4-4bff-4cfd-bbbe-df412ac9db10 | 2026-06-09 | Warnings | M001 |
| Sodium Bicarbonate Antacid | SODIUM BICARBONATE | NCS HealthCare of KY, LLC dba Vangard Labs | fde4ea0c-152b-4b79-a6d8-2b0dbd9107aa | 2026-06-04 | 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 |