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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | P & L Development, LLC | 0bb006f6-c360-4cd5-81e9-0776d99d79e8 | 2025-07-08 | Warnings | M012 |
| childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Meijer, Inc. | 026e530f-e133-4f20-bac5-354fbb647c9e | 2025-07-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY, INC | f59016f3-a8f8-4c95-9414-01440f0574d9 | 2025-07-08 | Warnings | M012 |
| ACTINEL PEDIATRIC | DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL | ACTIPHARMA, LLC | 6bb92d74-4893-40b8-af58-eb307155e876 | 2025-07-08 | Warnings | M012 |
| Nighttime Cold and Flu Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 776b7c67-56c7-420c-82b2-9a176d998396 | 2025-07-08 | Warnings | M012 |
| ACTICON | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 847014ab-86ae-40c5-8e7f-f1ddea14f1b3 | 2025-07-08 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN 400 MG | Cabinet Health, Inc. | 26a51b0e-039c-663c-e063-6394a90ad384 | 2025-07-07 | Warnings | M012 |
| EZ Nite Sleep | DIPHENHYDRAMINE HCL | Safeway, Inc. | 21a68c60-3005-43bb-8ec5-7982239c93f8 | 2025-07-07 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 8188b66a-5405-4e62-bde6-63ebc1f22b16 | 2025-07-04 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Meijer, Inc. | fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a | 2025-07-03 | Warnings | M012 |
| Cabinet Allergy Relief Refill Diphenhydramine HCI | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | d47553a4-ca15-4f0a-8177-d743a5c39cc5 | 2025-07-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Advanced Rx LLC | 20e164b8-4cbc-cf3f-e063-6394a90a9d0c | 2025-07-02 | Warnings | M012 |
| 24/7 Life Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENT | Lil' Drug Store Products, Inc. | f03430d4-8dbb-4fc0-e053-2a95a90a119d | 2025-07-02 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | KJD Pharma Private Limited | b109249a-a0be-41bd-b6ce-ef621b588ddc | 2025-07-02 | Warnings | M012 |
| Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy | 91c803c8-6cf8-4ff6-b376-ea6d65f9f227 | 2025-07-01 | Warnings | M012 |
| WALGREENS Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALGREENS CO. | cc2fdc6b-8319-47c8-b036-37dbd65d5833 | 2025-06-30 | Warnings | M012 |
| WALGREENS Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALGREENS CO. | 91c369b0-8620-4764-a85d-a86402d9489c | 2025-06-30 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl 25mg SoftGel | DIPHENHYDRAMINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | bb9a82b1-ea7a-4d10-bc00-05013e83c4d3 | 2025-06-30 | Warnings | M012 |
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS, LLC | 202f0661-461c-0333-e063-6294a90a96b5 | 2025-06-28 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | CVS Pharmacy | f038b713-0721-2bb5-e053-2a95a90a7842 | 2025-06-26 | 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 |