LoHist-D
- Product NDC
- 68047-159
- Requested package NDC
- 68047-159-16
- 11-digit product format
- 680470159
- Labeler code
- 68047
- Product ID
- 68047-159_57b0b63b-385b-72c7-e063-6394a90abd3d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Chlorpheniramine Maleate / Pseudoephedrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Larken Laboratories, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-07-30
- Substance
- CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 2; 30 mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-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
- LoHist-D
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORPHENIRAMINE MALEATE | 2 mg/5mL |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V1Q0O9OJ9Z | Internal UNII lookup |
| 6V9V2RYJ8N | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1053618 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| efaa354e-c25c-405b-9d30-001c2796978c | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Tukol Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | 27ab3d86-e960-4d83-aad1-d50d2c8e02a9 | 2024-10-14 | Warnings | M012 |
| HealthWise Chest Rub Lavender | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | 2472ce85-c701-4fcd-e063-6394a90a2765 | 2024-10-14 | Warnings | M012 |
| HealthWise Chest Rub Lemon | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | 24740d5a-aba1-0bd4-e063-6394a90ab2ca | 2024-10-14 | Warnings | M012 |
| Childrens Plus Cough and Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd43 | 2024-10-14 | Warnings | M012 |
| Theraflu Severe Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN | Haleon US Holdings LLC | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 2024-10-14 | Warnings | M012 |
| Cough Relief Adult | DEXTROMETHORPHAN HBR | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f5c57b32-69cb-469e-ad2d-64c00b5e66dc | 2024-10-14 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | Publix Super Markets Inc | 94c21df5-c631-4748-a833-288b2298055c | 2024-10-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 8eab9d79-69c1-44b8-9145-a7ebd887d54d | 2024-10-11 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | e4963eec-fb4a-425c-be19-f514b4f10a7f | 2024-10-11 | Warnings | M012 |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association | 1b4e87f8-3f9e-4865-9128-527d2d621593 | 2024-10-11 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | ff433512-55b7-4fc9-8a55-aff5cbb749ef | 2024-10-11 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 3170354a-4752-49a0-97ed-3d9db266a059 | 2024-10-11 | Warnings | M012 |
| Tukol Children Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | 235a6d2b-7302-410c-be35-4d5ff7bbdfce | 2024-10-11 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS Pharmacy | 6c7b0ea6-bff9-4fd2-9e00-64015c326ee8 | 2024-10-11 | Warnings | M012 |
| nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Meijer Distribution Inc | dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b | 2024-10-11 | Warnings | M012 |
| Signature Care Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 838d2f11-2ee4-4081-98c8-b87e79aa47c4 | 2024-10-11 | Warnings | M012 |
| Menthol | COUGH SUPPRESSANT | McKesson | 9d4def70-480f-f2fa-e053-2995a90a9877 | 2024-10-10 | Warnings | M012 |
| Menthol | COUGH SUPPRESSANT | McKesson | 9d5b4ef6-4eb8-41f6-e053-2a95a90a1350 | 2024-10-10 | Warnings | M012 |
| Tukol Sugar Free Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Genomma Lab USA | 95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho CF CF | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Efficient Laboratories Inc | 06e96e0c-f21f-e706-e063-6294a90a0780 | 2024-10-08 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68047-159-16 | 68047015916 | 473 mL in 1 BOTTLE (68047-159-16) | 473 ml | 2026-07-30 | No | No | Current |