Stona Cough
- Product NDC
- 49873-306
- 11-digit product format
- 498730306
- Labeler code
- 49873
- Product ID
- 49873-306_0bb8901e-89d4-b026-e063-6294a90ae77a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sato Pharmaceutical Co., Ltd.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2004-11-24
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 15; 100; 5 mg/1; mg/1; mg/1
- 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 49873-306-90 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 49873-306-90 | 5b2001dcd8f5… | 54b53d4dc9e4… |
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
- Stona Cough
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| GUAIFENESIN | 100 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
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 |
|---|---|
| 1245616 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| afc95c82-18da-487b-b4bb-51e0be0378da | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 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 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49873-306-01 | Stona Cough | 24 in 1 BOTTLE | TABLET | 24 | 7 | |
| 49873-306-01 | Stona Cough | 1 in 1 CARTON | TABLET | 1 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49873-306 | STONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20231205_afc95c82-18da-487b-b4bb-51e0be0378da.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 |
|---|---|---|---|---|---|---|
| Freegells Cough Drops Menthol Honey Lemon 80ct | MENTHOL | R.L. ALBERT & SON, INC | 61deea94-d0a9-4563-926b-53f255a7c425 | 2025-10-08 | Warnings | M012 |
| FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS | MENTHOL | R.L. ALBERT & SON, INC | c6b36350-386b-4346-bef0-a37ec11319c0 | 2025-10-08 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 3314b174-d5bb-4843-9288-9b9c5fce79d5 | 2025-10-08 | Warnings | M012 |
| OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution | DIPHENHYDRAMINE HCL | MEDWISE LIFESCIENCES INC. | 407b7cbb-7ebd-7b7e-e063-6394a90af501 | 2025-10-06 | Warnings | M012 |
| Quality Choice Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc | 2025-10-06 | Warnings | M012 |
| Halls Sugar Free Honey Lemon | MENTHOL | Mondelez Global LLC | 2b19fdd2-8088-47f2-be20-f220a6b825fc | 2025-10-06 | Warnings | M012 |
| Giltuss Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories, Inc | 40802fb6-c1ec-d7b0-e063-6394a90ab423 | 2025-10-06 | Warnings | M012 |
| Giltuss Diabetic | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories, Inc | 3f64c81a-bbfc-4575-e063-6294a90a6ed7 | 2025-10-06 | Warnings | M012 |
| TexaClear Severe Cough, Cold and Flu | CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GM Pharmaceuticals, INC | cb99e5b3-1908-43c9-b31f-d35e7ce58b44 | 2025-10-06 | Warnings | M012 |
| RoboHBr Cough SUPPRESSANT | DEXTROMETHORPHAN HBR | DXM Pharmaceutical, Inc | 0af624ce-191f-45e1-882b-e8acb90cc77b | 2025-10-06 | Warnings | M012 |
| RoboTablets | DEXTROMETHORPHAN | DXM Pharmaceutical, Inc | b92cf698-032d-4d8d-b19c-456c6338b094 | 2025-10-06 | Warnings | M012 |
| SinuLief | LORATADINE | RoseWell Pharmaceuticals LLC | 32619143-a782-3497-e063-6394a90aaaec | 2025-10-06 | Warnings | M012 |
| STAHIST AD | CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Magna Pharmaceuticals, Inc. | ccedbc38-2479-4c35-9f86-a9f29bcfab3f | 2025-10-03 | Warnings | M012 |
| Childrens PediaClear 8 | PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 8e524967-d01c-4c93-9198-c42f15fe3fe0 | 2025-10-03 | Warnings | M012 |
| Childrens PediaClear PD | TRIPROLIDINE HYDROCHLORIDE | GM Pharmaceuticals, INC | f3ede5b7-1b0f-493a-b647-4459affc7e54 | 2025-10-03 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | InvaTech Pharma Solutions LLC | 40288ecf-043d-eb9e-e063-6394a90ac0a7 | 2025-10-02 | Warnings | M012 |
| Guaifenesin 400 | GUAIFENESIN TABLETS 400 | InvaTech Pharma Solutions LLC | 40291505-55ca-0759-e063-6394a90acee1 | 2025-10-02 | M012 | |
| CVS Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy | 3dd5b783-5b64-24b5-e063-6394a90ab4ee | 2025-10-02 | Warnings | M012 |
| Acetaminophen and Diphenhydramine citrate | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE | InvaTech Pharma Solutions LLC | 403a88fa-e06b-9b6e-e063-6394a90a97b8 | 2025-10-02 | Warnings | M012 |
| Equaline childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | United Natural Foods, Inc. dba UNFI | 3053f6d7-0eff-488c-8901-770dcc62af06 | 2025-10-02 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1245616 | dextromethorphan HBr 15 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | afc95c82-18da-487b-b4bb-51e0be0378da | 7 |
| 1245616 | dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | afc95c82-18da-487b-b4bb-51e0be0378da | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49873-306-01 | 49873030601 | 1 BOTTLE in 1 CARTON (49873-306-01) / 24 TABLET in 1 BOTTLE | 1 bottle | 2004-11-24 | 0000-00-00 | No | No | Current |