Nasal Decongestant PE
- Product NDC
- 21130-453
- 11-digit product format
- 211300453
- Labeler code
- 21130
- Product ID
- 21130-453_9fc2ece9-cf33-429f-938e-1e96d1cbdb54
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Better Living Brands, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-01-14
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 21130-453 | 21130-453-44 | D | Discontinued by firm | 2026-10-12 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Nasal Decongestant PE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049182 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0153294d-7f52-4d92-8db8-daeca3e29a3b | 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 |
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 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 |
|---|---|---|---|---|---|---|
| 21130-453-07 | Nasal Decongestant PE | 18 in 1 BLISTER PACK | TABLET, FILM COATED | 18 | 21 | |
| 21130-453-07 | Nasal Decongestant PE | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 21 | |
| 21130-453-44 | Nasal Decongestant PE | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 21 | |
| 21130-453-44 | Nasal Decongestant PE | 18 in 1 BLISTER PACK | TABLET, FILM COATED | 18 | 21 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Sinus PE Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 28a4ec37-11dd-4134-81aa-851f081bf088 | 2026-08-17 | Warnings | M012 |
| CVS Health No Drip | NASAL MIST | CVS PHARMACY,INC. | 60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa | 2026-08-17 | Warnings | M012 |
| Daytime Cold and Cough and NightTime Cold and Congestion Childrens | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreens | 2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3 | 2026-08-17 | Warnings | M012 |
| CVS Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | CVS HEALTH | f01ab8ef-d29a-4e33-8a14-4c57ccdcc0d6 | 2026-08-17 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | KROGER COMPANY | 30d50bbe-0a14-c985-e063-6294a90a47b3 | 2026-08-16 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 77f87e19-a9d5-479d-9434-bbde13210bfb | 2026-08-15 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. DBA Leader | b1c2055b-4b5a-4fa2-b600-8930c9c8524c | 2026-08-15 | Warnings | M012 |
| Nighttime HBP Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY | 146c9a62-0418-4b5d-9074-5be8a05f3f93 | 2026-08-15 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 610accad-2f8b-4605-9357-a58e6e18d417 | 2026-08-15 | Warnings | M012 |
| Nasal Decongestant Maximum Strength, Non-Drowsy | PSEUDOEPHEDRINE HCL | Amerisource Bergen | 1fdb1ba5-4072-4baf-9e30-f01d57bf6d82 | 2026-08-15 | Warnings | M012 |
| Cold and Flu Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | 32c67914-d7cf-40ee-8682-0ba8ed691287 | 2026-08-15 | Warnings | M012 |
| CVS Childrens COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | CVS PHARMACY | 27820bce-6638-4f17-ac66-62b02b76bec3 | 2026-08-14 | Warnings | M012 |
| CVS PHARMACY Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE | CVS PHARMACY, INC. | 004e104b-d6ff-48d5-8685-cd1bff45399a | 2026-08-14 | Warnings | M012 |
| CHILDRENS DIMETAPP COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS PHARMACY | 7babf4f6-ca0a-44a7-b1ea-d60e20d36f15 | 2026-08-14 | Warnings | M012 |
| Nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | e7c8ffed-83b8-4088-b72c-d937e93f8b54 | 2026-08-14 | Warnings | M012 |
| CVS Mucus Relief DM and Overnight Cold and Flu | DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL | CVS | 75520b77-d40b-4f43-b92a-7a3eba5b493f | 2026-08-14 | Warnings | M012 |
| CVS Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | bb24c298-1d00-4378-8de3-b4056220fa75 | 2026-08-14 | Warnings | M012 |
| SEVERE COLD PLUS FLU DAYTIME NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS Pharmacy,Inc. | 6cb1d08b-e544-4084-b9ed-1e0d99a709c8 | 2026-08-14 | Warnings, Adverse reactions | M012 |
| Theraflu Relief Max Strength Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | 932a3d40-9b52-4e91-bc61-6fd506f2d9e6 | 2026-08-14 | Warnings | M012 |
| Multi Symptom Severe Cold and Nighttime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy,Inc. | 91063edd-1e7e-41e9-8412-b14ef3749018 | 2026-08-14 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049182 | phenylephrine HCl 10 MG Oral Tablet | PSN | 0153294d-7f52-4d92-8db8-daeca3e29a3b | 21 |
| 1049182 | phenylephrine hydrochloride 10 MG Oral Tablet | SCD | 0153294d-7f52-4d92-8db8-daeca3e29a3b | 21 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 21130-453-07 | 21130045307 | 2 BLISTER PACK in 1 CARTON (21130-453-07) / 18 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2005-01-14 | 0000-00-00 | No | No | Current |
| 21130-453-44 | 21130045344 | 1 in 1 CARTON | Historical |