childrens fever reducer and pain reliever
- Product NDC
- 11822-0595
- 11-digit product format
- 118220595
- Labeler code
- 11822
- Product ID
- 11822-0595_eb8454b5-d82a-47b3-b1c5-cdb198f2ba63
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1997-09-23
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- 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 | 11822-0595 | 11822-0595-5 | D | Discontinued by firm | 2026-10-27 |
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
- childrens fever reducer and pain reliever
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 307668 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f6e51c4b-2941-4862-8262-bd9716324841 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 11822-0595-4 | 2023-09-20 | Rite Aid Corporation Children’s Fever Reducer & Pain Reliever Drug Facts |
| 11822-0595-5 | 2023-09-20 | Rite Aid Corporation Children’s Fever Reducer & Pain Reliever Drug Facts |
| 11822-0595-4 | 2023-01-30 | Rite Aid Corporation Children’s Fever Reducer & Pain Reliever Drug Facts |
| 11822-0595-5 | 2023-01-30 | Rite Aid Corporation Children’s Fever Reducer & Pain Reliever Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-0595-4 | childrens fever reducer and pain reliever | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 9 | |
| 11822-0595-4 | childrens fever reducer and pain reliever | 1 in 1 CARTON | SUSPENSION | 1 | 9 | |
| 11822-0595-5 | childrens fever reducer and pain reliever | 1 in 1 CARTON | SUSPENSION | 1 | 9 | |
| 11822-0595-5 | childrens fever reducer and pain reliever | 148 mL in 1 BOTTLE | SUSPENSION | 148 | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-0595 | CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION] | 9 | Current NDC, Legacy NDC, 4 package rows | 20241004_f6e51c4b-2941-4862-8262-bd9716324841.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 |
|---|---|---|---|---|---|---|
| Regular Strength Pain Relief | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 6158e954-32d8-4718-e053-2a91aa0a27f3 | 2024-12-31 | Warnings | M013 |
| Aspirin | ASPIRIN | Advanced Rx Pharmacy of Tennessee, LLC | f8375029-e567-c6a5-e053-6394a90a5b67 | 2024-12-31 | Warnings | M013 |
| Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Dollar General | 4907056d-6013-46b1-ae86-469dc3001591 | 2024-12-31 | Warnings | M013 |
| Pediacare Childrens Grape | ACETAMINOPHEN | RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH | f9d531a2-234c-4feb-8f05-212dbee83dfe | 2024-12-30 | Warnings | M013 |
| Pediacare Childrens Acetaminophen Grape | ACETAMINOPHEN | RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH | 596372c7-eca3-4527-8e22-ab0751e2526b | 2024-12-30 | Warnings | M013 |
| Bayer Genuine Aspirin | BAYER GENUINE ASPIRIN | Lil' Drug Store Products, Inc. | d17834d7-cb3e-6bf2-e053-2a95a90ae5c1 | 2024-12-30 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN 500 MG, FILM-COATED CAPLET | Lil' Drug Store Products, Inc. | e5fd2b46-683e-4cf5-e053-2995a90a5512 | 2024-12-30 | Warnings | M013 |
| Night Time Severe Cold and Cough Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Chain Drug Consortium, LLC | c8e9b57b-83e9-46c5-9791-02c4c2b94004 | 2024-12-29 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC. | 1608b4f0-bf20-4024-b8f2-20a4df7a4b21 | 2024-12-26 | Warnings | M013 |
| Aspirin | ASPIRIN | Advance Pharmaceutical Inc. | f6a9ea44-08b8-4a33-bfbd-68cb2d852c39 | 2024-12-26 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | cfc7eac3-35be-4002-b8ef-be1dfc8caf69 | 2024-12-26 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | a3031139-4709-43f2-95a8-89840c595f7f | 2024-12-26 | Warnings | M013 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | WALGREENS CO. | 98bb28ed-d146-ca3d-e053-2a95a90a9eaf | 2024-12-26 | Warnings | M013 |
| Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg | ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG | WALGREENS CO. | 982faa74-d498-cd1e-e053-2995a90afa1e | 2024-12-25 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | AptaPharma Inc. | 11bf6e1b-aed9-4f8f-9f03-ea911ae9f702 | 2024-12-23 | Warnings | M013 |
| Rugby Regular Strength Acetaminophen | ACETAMINOPHEN | RUGBY LABORATORIES | 295b0d00-4d4a-405f-9325-d01c5d4f3ed4 | 2024-12-20 | Warnings | M013 |
| Walgreens Pain Relief Powder | ASPIRIN AND CAFFEINE | Walgreens Co. | 61493d34-2432-4683-9b32-e1851a4337be | 2024-12-18 | Warnings | M013 |
| Reese Headache Powders | ASPIRIN AND CAFFEINE | Reese Pharmaceutical Co | 386f7a6c-4bfc-4140-a67b-07f6b520d58f | 2024-12-18 | Warnings | M013 |
| NobleAid PAIN RELIEVER | ASPIRIN | Noble Otc LLC | aa08e488-2f69-4d7e-86ba-ccfad563edcf | 2024-12-18 | Warnings | M013 |
| Dollar General Headache Powders | ASPIRIN AND CAFFEINE | Dolgencorp, LLC | 11b0271b-d65c-49c4-a081-d71044a0e04c | 2024-12-18 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | f6e51c4b-2941-4862-8262-bd9716324841 | 9 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | f6e51c4b-2941-4862-8262-bd9716324841 | 9 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | f6e51c4b-2941-4862-8262-bd9716324841 | 9 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | f6e51c4b-2941-4862-8262-bd9716324841 | 9 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | f6e51c4b-2941-4862-8262-bd9716324841 | 9 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | f6e51c4b-2941-4862-8262-bd9716324841 | 9 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | f6e51c4b-2941-4862-8262-bd9716324841 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11822-0595-4 | 11822059504 | 1 BOTTLE in 1 CARTON (11822-0595-4) / 118 mL in 1 BOTTLE | 1 bottle | 1997-09-23 | 0000-00-00 | No | No | Current |
| 11822-0595-5 | 11822059505 | 1 BOTTLE in 1 CARTON (11822-0595-5) > 148 mL in 1 BOTTLE | 1 bottle | 1997-09-23 | 0000-00-00 | No | No | Current |