Aveeno Baby Calming Comfort
- Product NDC
- 69968-0629
- 11-digit product format
- 699680629
- Labeler code
- 69968
- Product ID
- 69968-0629_21eb4c57-d7ff-d06c-e063-6394a90ae472
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimethicone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Kenvue Brands LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-06-01
- Substance
- DIMETHICONE
- Active strength
- 12 mg/mL
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 69968-0629 | 69968-0629-8 | 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
- Aveeno Baby Calming Comfort
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 12 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 876980 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 567b1481-b783-45f9-af38-5630c9edf044 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69968-0629-1 | Aveeno Baby Calming Comfort | 532 mL in 1 BOTTLE, PUMP | LOTION | 532 | 5 | |
| 69968-0629-8 | Aveeno Baby Calming Comfort | 227 mL in 1 TUBE | LOTION | 227 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69968-0629 | AVEENO BABY CALMING COMFORT (DIMETHICONE) LOTION [KENVUE BRANDS LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241103_567b1481-b783-45f9-af38-5630c9edf044.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 |
|---|---|---|---|---|---|---|
| SUPRADERM | WHITE PETROLATUM, LANOLIN | Olen Skin Care Corporation | 4e7199bd-52c6-48e9-9c78-c84e45412faf | 2026-06-10 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 509ee758-9d53-220c-e063-6394a90a4bd5 | 2026-06-09 | Warnings | M016 |
| BABY BUM DIAPER | ZINC OXIDE | Creative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare | 53d8a654-aaec-6f91-e063-6394a90a7351 | 2026-06-09 | Warnings | M016 |
| CELISTAR MICRONEEDLING INFUSION | HYALURONATE SODIUM | Guangdong Outeli Biotechnology Co., Ltd. | 53de46a7-3947-70a7-e063-6294a90ab829 | 2026-06-09 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 3c448cf7-8ca5-c7f7-e063-6294a90a75ff | 2026-06-08 | Warnings | M016 |
| WOODSLEEP Wild Yam Cream | GLYCERIN | Shantou Woodsleep Biotechnology Co., Ltd. | 53b992fd-5759-57bb-e063-6394a90a1600 | 2026-06-08 | Warnings | M016 |
| XIMONTH Fungi Free Bee Venom Nail Soothing Serum | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 53bab969-8407-6334-e063-6294a90aa5d1 | 2026-06-08 | Warnings | M016 |
| GNP Calamine Topical Suspension | CALAMINE 8% AND ZINC OXIDE 8% | Amerisource Bergen | 777b0e66-1bce-4483-9dad-c46796fd6f23 | 2026-06-04 | Warnings | M016 |
| GNP Caldyphen | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Amerisource Bergen | 515c58d7-0dc4-45e7-9155-e5270a16290e | 2026-06-04 | Warnings | M016 |
| First Aid Beauty Sensitive Skin Bestsellers Kit | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 535a0e8e-6bb4-6652-e063-6394a90aa7ff | 2026-06-03 | Warnings | M016 |
| Quad Wash | DIMETHICONE | Dynarex Corporation | 535dc862-6a18-26c9-e063-6294a90a3d4a | 2026-06-03 | Warnings | M016 |
| First Aid Beauty Sensitive Skin Bestsellers Kit | COLLOIDAL OATMEAL | JCS Global Distribution, Inc. | 535e42a1-8b14-324d-e063-6394a90a3f65 | 2026-06-03 | Warnings | M016 |
| Petroleum Jelly Skin Protectant | WHITE PETROLATUM | Acme United Corporation | 535e94bb-21e8-90be-e063-6394a90a37bb | 2026-06-03 | Warnings | M016 |
| ADVANCED HEALING | PETROLATUM | Rejoice International Corp. | 532c7e5a-4d05-3bd0-e063-6294a90aee00 | 2026-06-01 | Warnings | M016 |
| PUTRIZEN 40 UREA | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 533dadbc-6f20-d880-e063-6394a90a753f | 2026-06-01 | Warnings | M016 |
| ADVANCED HEALING BALM | PETROLATUM | Rejoice International Corp. | 53285d82-3755-ca78-e063-6394a90a5019 | 2026-05-31 | Warnings | M016 |
| KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery | COLLOIDAL OATMEAL | LOreal USA Products Inc | 22e088b9-b3b1-4c34-be12-a5a31200ec25 | 2026-05-29 | Warnings | M016 |
| Acne Relief Cream | NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT | Guangzhou Senmai Biotechnology Co.,Ltd. | 53008b89-89ab-7650-e063-6294a90ac16c | 2026-05-29 | Warnings | M016 |
| PURE PETROLATUM | PETROLATUM | VASA COSMETICS PRIVATE LIMITED | 52efd466-49bd-bbdf-e063-6394a90aa108 | 2026-05-28 | Warnings | M016 |
| TheraCare Vitamin A and D plus E | PETROLATUM | Veridian Healthcare | 52e0e248-6c04-feb9-e063-6394a90add46 | 2026-05-28 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 876980 | dimethicone 1.2 % Topical Lotion | PSN | 567b1481-b783-45f9-af38-5630c9edf044 | 5 |
| 876980 | dimethicone 12 MG/ML Topical Lotion | SCD | 567b1481-b783-45f9-af38-5630c9edf044 | 5 |
| 876980 | dimethicone 1.2 % Topical Lotion | SY | 567b1481-b783-45f9-af38-5630c9edf044 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69968-0629-1 | 69968062901 | 532 mL in 1 BOTTLE, PUMP (69968-0629-1) | 532 ml | 2020-06-01 | 0000-00-00 | No | No | Current |
| 69968-0629-8 | 69968062908 | 227 mL in 1 TUBE | 227 ml | Historical |