S2
- Product NDC
- 0487-5901
- 11-digit product format
- 004875901
- Labeler code
- 0487
- Product ID
- 0487-5901_495453e6-2060-edaa-e063-6394a90a8a5d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- racepinephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Nephron Pharmaceuticals Corporation
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2000-01-01
- Substance
- RACEPINEPHRINE HYDROCHLORIDE
- Active strength
- 11.25 mg/.5mL
- 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
- S2
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RACEPINEPHRINE HYDROCHLORIDE | 11.25 mg/.5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 336096P2WE | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dd1b35c7-b23b-4b95-8162-df3d263fe32e | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0487-5901-99 | S2 | 30 in 1 CARTON | SOLUTION | 30 | 12 | |
| 0487-5901-99 | S2 | 1 in 1 POUCH | SOLUTION | 1 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0487-5901-02 | EA - Each | 0487-5901 | e4fa89c2-def9-4c41-9c97-ccaf02f5b5cf | 1 | 2012-07-24 |
| 0487-5901-10 | EA - Each | 0487-5901 | 4e462d6e-f2d0-4ea7-bcfa-2073e6f5109f | 1 | 2013-02-13 |
| 0487-5901-99 | EA - Each | 0487-5901 | 530e7c42-5bd7-483e-96d6-682b76349b33 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| RACEPINEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 336096P2WE | S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION] | 7 | |
| RACEPINEPHRINE | ACTIVE MOIETY | GR0L9S3J0F | S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION] | 7 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION] | 7 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION] | 7 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION] | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION] | 7 |
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 |
|---|---|---|---|---|---|---|
| Cough Drops | MENTHOL | The Kroger CO | f6da2e02-42c7-1ede-e053-6394a90aff5f | 2025-02-09 | Warnings | M012 |
| MUCOSA DM | GUAIFENESIN DEXTROMETHORPHAN | TIME CAP LABORATORIES, INC. | 62c1f4aa-6571-414c-9a58-31e107b7db97 | 2025-02-08 | Warnings | M012 |
| Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | 2d95d5a4-34dc-e195-e063-6394a90a39da | 2025-02-07 | Warnings | M012 |
| Halls Sugar Free Honey Lemon | MENTHOL | Mondelez Global LLC | 5d56ccd2-1c28-4750-9454-44809091ad2f | 2025-02-05 | Warnings | M012 |
| SanaTos Mucus Relief Cold Toddlers | DEXTROMETHORPHAN HBR, GUAIFENESIN | Pharmadel LLC | 60672feb-1421-651e-e053-2a91aa0af41d | 2025-02-04 | Warnings | M012 |
| SofSkin Vaporizing Chest Rub and Cough Suppressant | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Viny Health and Beauty Inc | 34626cf5-64fc-15c0-e063-6294a90aa310 | 2025-02-04 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS PHARMACY, INC | 17922df7-7867-4300-bd99-55aee7b60606 | 2025-02-04 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | f4b8ff54-47b5-4d18-bf4e-b101abb22a24 | 2025-02-03 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | f40bfdfc-1cb4-4604-9790-fb8d1d5173c6 | 2025-01-31 | Warnings | M012 |
| NIGHTIME COLD AND FLU | NIGHTIME COLD AND FLU | TARGET CORP | 9dee9b92-eac9-b07d-e053-2995a90a0602 | 2025-01-31 | Warnings | M012 |
| Rugby Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Bryant Ranch Prepack | 7b23faa9-40c8-4cea-b9fb-487cce2664af | 2025-01-31 | Warnings | M012 |
| BENADRYL Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 224ba2a3-1a93-29c8-e063-6394a90a9bef | 2025-01-30 | Warnings | M012 |
| Extra Strength Nite-Time Pain Relief | 430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLET | WALGREENS | c25cff5a-93f5-62aa-e053-2a95a90aa7b4 | 2025-01-30 | Warnings | M012 |
| NIGHTTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WALGREENS | dbf5c814-4e69-13ac-e053-2a95a90a49a3 | 2025-01-30 | Warnings | M012 |
| Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | WALGREENS | f3770976-de73-52b8-e053-2995a90aad4f | 2025-01-30 | Warnings | M012 |
| Dextromethorphan HBr and Guaifenesin Oral Solution | DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION | KESIN PHARMA CORPORATION | 284eae44-81bc-400c-e063-6394a90af446 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26c82bc3-5753-4d56-96a4-a3f9c8c267d0 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 8095b211-8ae7-44e5-b89a-b7f730e28d51 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2cf2f35b-5d59-e3ff-e063-6294a90a9b45 | 2025-01-30 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy, Daytime | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5 | 2025-01-30 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310133 | racepinephrine 2.25 % Inhalation Solution | PSN | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 12 |
| 863968 | S-2, 2.25 % Inhalation Solution | PSN | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 12 |
| 863968 | racepinephrine 22.5 MG/ML Inhalation Solution [S-2] | SBD | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 12 |
| 310133 | racepinephrine 22.5 MG/ML Inhalation Solution | SCD | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 12 |
| 310133 | racepinephrine 11.25 MG per 0.5 ML Inhalation Solution | SY | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 12 |
| 310133 | racepinephrine 2.25 % Inhalation Solution | SY | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 12 |
| 863968 | S-2 11.25 MG (racepinephrine hydrochloride 13.5 MG) per 0.5 ML Inhalation Solution | SY | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 12 |
| 863968 | S-2 2.25 % Inhalation Solution | SY | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0487-5901-99 | 00487590199 | 30 POUCH in 1 CARTON (0487-5901-99) / 1 VIAL, SINGLE-USE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-USE | 30 pouch | 2000-01-01 | 0000-00-00 | No | No | Current |